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FDA 510(k)

AXICARE BREAST PUMP MODEL

K-Number: K811403 · 1981-06-12

ApplicantNeonatal Corp.
Decision Date1981-06-12
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AXICARE BREAST PUMP MODEL is the device name listed in this FDA 510(k) record. The listed applicant is Neonatal Corp.. It received FDA 510(k) clearance on 1981-06-12 under 510(k) number K811403. 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 AXICARE BREAST PUMP MODEL?

AXICARE BREAST PUMP MODEL is a medical device that received FDA 510(k) clearance on 1981-06-12. The listed applicant is Neonatal Corp.. The 510(k) number is K811403.

When did AXICARE BREAST PUMP MODEL receive FDA 510(k) clearance?

AXICARE BREAST PUMP MODEL received FDA 510(k) clearance on 1981-06-12, under 510(k) number K811403.

Who is the listed applicant for AXICARE BREAST PUMP MODEL?

The FDA 510(k) record lists Neonatal Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AXICARE BREAST PUMP MODEL?

The FDA product code for AXICARE BREAST PUMP MODEL 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.

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Other records listing Neonatal Corp. 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.

K811364AXICARE BREAST SHELLK811707AXICUT DISPOSABLE SCALPEL

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

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

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