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FDA 510(k)

GUARDIAN AND ANDINO MODELS

K-Number: K932991 · 1994-01-28

ApplicantColtemp, Inc.
Decision Date1994-01-28
Product CodeFLK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GUARDIAN AND ANDINO MODELS is the device name listed in this FDA 510(k) record. The listed applicant is Coltemp, Inc.. It received FDA 510(k) clearance on 1994-01-28 under 510(k) number K932991. The device is classified under product code FLK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUARDIAN AND ANDINO MODELS?

GUARDIAN AND ANDINO MODELS is a medical device that received FDA 510(k) clearance on 1994-01-28. The listed applicant is Coltemp, Inc.. The 510(k) number is K932991.

When did GUARDIAN AND ANDINO MODELS receive FDA 510(k) clearance?

GUARDIAN AND ANDINO MODELS received FDA 510(k) clearance on 1994-01-28, under 510(k) number K932991.

Who is the listed applicant for GUARDIAN AND ANDINO MODELS?

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

What is the FDA product code for GUARDIAN AND ANDINO MODELS?

The FDA product code for GUARDIAN AND ANDINO MODELS is FLK.

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Related Devices (Code: FLK)

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.

K960185AMSINO CLINICAL THERMOMETERAmsia Intl., Inc.K960224GERATHERM MERCUIRY FREE CLINICAL THERMOMETERRg Ent., Inc.K953465KENTEMPKentron Health Care, Inc.K942483CLINICAL GLASS THERMOMETERMakol Medical Instruments Corp.K941673MEDIAID UNIVERSAL THERMOMETERPolymedica Industries, Inc.K940380AMG MED BRAND CLINICAL GLASS THERMOMETERAmg Medical, 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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