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FDA 510(k)

IVEX MODEL NO. BP 3000 BREASTPUMP

K-Number: K893545 · 1990-02-16

ApplicantIvex Medical, Inc.
Decision Date1990-02-16
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

IVEX MODEL NO. BP 3000 BREASTPUMP is the device name listed in this FDA 510(k) record. The listed applicant is Ivex Medical, Inc.. It received FDA 510(k) clearance on 1990-02-16 under 510(k) number K893545. 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 IVEX MODEL NO. BP 3000 BREASTPUMP?

IVEX MODEL NO. BP 3000 BREASTPUMP is a medical device that received FDA 510(k) clearance on 1990-02-16. The listed applicant is Ivex Medical, Inc.. The 510(k) number is K893545.

When did IVEX MODEL NO. BP 3000 BREASTPUMP receive FDA 510(k) clearance?

IVEX MODEL NO. BP 3000 BREASTPUMP received FDA 510(k) clearance on 1990-02-16, under 510(k) number K893545.

Who is the listed applicant for IVEX MODEL NO. BP 3000 BREASTPUMP?

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

What is the FDA product code for IVEX MODEL NO. BP 3000 BREASTPUMP?

The FDA product code for IVEX MODEL NO. BP 3000 BREASTPUMP 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 Ivex Medical, 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.

K884563OXYGEN CONCENTRATOR W/CONCENTRATION 3LPM 93% +/-3%K883837MIKADO AC 405

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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