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FDA 510(k)

AXICARE CM-14 AUTOMATIC BREAST PUMP

K-Number: K853107 · 1985-11-19

ApplicantCrystal Medical Products, Inc.
Decision Date1985-11-19
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AXICARE CM-14 AUTOMATIC BREAST PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Crystal Medical Products, Inc.. It received FDA 510(k) clearance on 1985-11-19 under 510(k) number K853107. 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 CM-14 AUTOMATIC BREAST PUMP?

AXICARE CM-14 AUTOMATIC BREAST PUMP is a medical device that received FDA 510(k) clearance on 1985-11-19. The listed applicant is Crystal Medical Products, Inc.. The 510(k) number is K853107.

When did AXICARE CM-14 AUTOMATIC BREAST PUMP receive FDA 510(k) clearance?

AXICARE CM-14 AUTOMATIC BREAST PUMP received FDA 510(k) clearance on 1985-11-19, under 510(k) number K853107.

Who is the listed applicant for AXICARE CM-14 AUTOMATIC BREAST PUMP?

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

What is the FDA product code for AXICARE CM-14 AUTOMATIC BREAST PUMP?

The FDA product code for AXICARE CM-14 AUTOMATIC 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.

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Other records listing Crystal Medical Products, 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.

K861513LA DIFFUSION TECHNIQUE, KTY CM-10 BREAST PUMPK850753NATURAL MOTHER BREAST PUMPK850242CRYSTAL MANUAL BREAST PUMPK842766CRYSTAL MEDICAL MILK COLLECTION 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

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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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