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FDA 510(k)

SQA

K-Number: K894949 · 1989-12-29

ApplicantUnited Medical Systems, Inc.
Decision Date1989-12-29
Product CodePOV
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SQA is the device name listed in this FDA 510(k) record. The listed applicant is United Medical Systems, Inc.. It received FDA 510(k) clearance on 1989-12-29 under 510(k) number K894949. The device is classified under product code POV. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SQA?

SQA is a medical device that received FDA 510(k) clearance on 1989-12-29. The listed applicant is United Medical Systems, Inc.. The 510(k) number is K894949.

When did SQA receive FDA 510(k) clearance?

SQA received FDA 510(k) clearance on 1989-12-29, under 510(k) number K894949.

Who is the listed applicant for SQA?

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

What is the FDA product code for SQA?

The FDA product code for SQA is POV.

Other records listing United Medical Systems, 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.

K072538PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTERK032958PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000K893003TOCOLYTIC SITE CARE SUP KIT #1001/100A/CARRY CASEK863645SCHULMAN DOUBLE UMBILICAL CORD CLAMP NO. 1000

Related Devices (Code: POV)

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.

K252228Seaman Pro/SeamanCheckcells, Inc.K242830LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality AnalyzerBonraybio Co., Ltd.K242388LensHooke X12 PRO Semen Analysis SystemBonraybio Co., Ltd.K243114SQA-iOw Sperm Quality AnalyzerMedical Electronic Systems , Ltd.K241628YO Home Sperm TestMedical Electronic Systems , Ltd.K220828SQA-iO Sperm Quality AnalyzerMedical Electronic Systems , 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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