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FDA 510(k)

INCUBATOR, PORTABLE, ACT-STAT

K-Number: K770914 · 1977-08-04

ApplicantThermolyne Corp.
Decision Date1977-08-04
Product CodeKQG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

INCUBATOR, PORTABLE, ACT-STAT is the device name listed in this FDA 510(k) record. The listed applicant is Thermolyne Corp.. It received FDA 510(k) clearance on 1977-08-04 under 510(k) number K770914. The device is classified under product code KQG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INCUBATOR, PORTABLE, ACT-STAT?

INCUBATOR, PORTABLE, ACT-STAT is a medical device that received FDA 510(k) clearance on 1977-08-04. The listed applicant is Thermolyne Corp.. The 510(k) number is K770914.

When did INCUBATOR, PORTABLE, ACT-STAT receive FDA 510(k) clearance?

INCUBATOR, PORTABLE, ACT-STAT received FDA 510(k) clearance on 1977-08-04, under 510(k) number K770914.

Who is the listed applicant for INCUBATOR, PORTABLE, ACT-STAT?

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

What is the FDA product code for INCUBATOR, PORTABLE, ACT-STAT?

The FDA product code for INCUBATOR, PORTABLE, ACT-STAT is KQG.

Related Clinical Trials

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Other records listing Thermolyne 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.

K792095HISTO-CENTER IIK771617SPECI-MIXK760928BLOOD BANK DRI-BATH

Related Devices (Code: KQG)

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.

K050821COAGCARE ANTICOAGULATION MANAGEMENT SYSTEMZycareK021976FIBRON-1, FIBRON-4, QUIKCOAG, FIBRONVital Scientific N.V.K992130PACIFIC HEMOSTASIS THROMBOSCREEN 400CPacific HemostasisK991321PACIFIC HEMOSTASIS THROMBOSCREEN 200Pacific HemostasisK983475HEMOCHRON RESPONSEInternational Technidyne Corp.K902614ELVI 828 DIGICLOT MULTISCANLogos Scientific, Inc.

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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