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FDA 510(k)

HYDROCHECK MICRO FILTER

K-Number: K970488 · 1997-11-04

ApplicantWhite River Concepts
Decision Date1997-11-04
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HYDROCHECK MICRO FILTER is the device name listed in this FDA 510(k) record. The listed applicant is White River Concepts. It received FDA 510(k) clearance on 1997-11-04 under 510(k) number K970488. 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 HYDROCHECK MICRO FILTER?

HYDROCHECK MICRO FILTER is a medical device that received FDA 510(k) clearance on 1997-11-04. The listed applicant is White River Concepts. The 510(k) number is K970488.

When did HYDROCHECK MICRO FILTER receive FDA 510(k) clearance?

HYDROCHECK MICRO FILTER received FDA 510(k) clearance on 1997-11-04, under 510(k) number K970488.

Who is the listed applicant for HYDROCHECK MICRO FILTER?

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

What is the FDA product code for HYDROCHECK MICRO FILTER?

The FDA product code for HYDROCHECK MICRO FILTER is HGX.

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Other records listing White River Concepts 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.

K964679WHITE RIVER AUTOMATIC BREAST PUMPK971231WHITE RIVER MINI MANUAL BREAST PUMP

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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