Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT

K-Number: K082307 · 2008-09-11

ApplicantEvenflo Company, Inc.
Decision Date2008-09-11
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT is the device name listed in this FDA 510(k) record. The listed applicant is Evenflo Company, Inc.. It received FDA 510(k) clearance on 2008-09-11 under 510(k) number K082307. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT?

EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT is a medical device that received FDA 510(k) clearance on 2008-09-11. The listed applicant is Evenflo Company, Inc.. The 510(k) number is K082307.

When did EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT receive FDA 510(k) clearance?

EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT received FDA 510(k) clearance on 2008-09-11, under 510(k) number K082307.

Who is the listed applicant for EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT?

The FDA 510(k) record lists Evenflo Company, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT?

The FDA product code for EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT is HGX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Evenflo Company, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K102600SIMPLYGO BREAST PUMPK100435AMEDA PLATINUM BREAST PUMPK092770SIMPLYGO HANDS FREE BREAST PUMPK053493BERRY FRUITY TEETHERK052909EVENFLO ELAN BREAST PUMPK022933EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT

View all 8 devices →

Related Devices (Code: HGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254203Wearable Breast Pump (Model S36)Shenzhen TPH Technology Co., Ltd.K261622Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62)Philips Consumer Lifestyle B.V.K262774Wearable breast pump (Model: XN/MD-2249BS, ZFHF)Guangdong Horigen Mother & Baby Products Co., Ltd.K260643Cimilre Dual MaxCimilre Co., Ltd.K261298Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))Guangdong Youmeng Electrical Technology Co., Ltd.K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑