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FDA 510(k)

EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP

K-Number: K960726 · 1996-07-22

ApplicantEvenflo Co., Inc.
Decision Date1996-07-22
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Evenflo Co., Inc.. It received FDA 510(k) clearance on 1996-07-22 under 510(k) number K960726. 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 SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP?

EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP is a medical device that received FDA 510(k) clearance on 1996-07-22. The listed applicant is Evenflo Co., Inc.. The 510(k) number is K960726.

When did EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP receive FDA 510(k) clearance?

EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP received FDA 510(k) clearance on 1996-07-22, under 510(k) number K960726.

Who is the listed applicant for EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP?

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

What is the FDA product code for EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP?

The FDA product code for EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP 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 Co., 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.

K983776EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMPK960727EVENFLO NATURAL MOTHER ELECTRIC BREAST PUMP KIT

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.

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