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FDA 510(k)

ADJUST-A-TEMP MICRO

K-Number: K841603 · 1984-12-07

ApplicantSuncoast Medical Manufacturers, Inc.
Decision Date1984-12-07
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ADJUST-A-TEMP MICRO is the device name listed in this FDA 510(k) record. The listed applicant is Suncoast Medical Manufacturers, Inc.. It received FDA 510(k) clearance on 1984-12-07 under 510(k) number K841603. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADJUST-A-TEMP MICRO?

ADJUST-A-TEMP MICRO is a medical device that received FDA 510(k) clearance on 1984-12-07. The listed applicant is Suncoast Medical Manufacturers, Inc.. The 510(k) number is K841603.

When did ADJUST-A-TEMP MICRO receive FDA 510(k) clearance?

ADJUST-A-TEMP MICRO received FDA 510(k) clearance on 1984-12-07, under 510(k) number K841603.

Who is the listed applicant for ADJUST-A-TEMP MICRO?

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

What is the FDA product code for ADJUST-A-TEMP MICRO?

The FDA product code for ADJUST-A-TEMP MICRO is GEI.

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Other records listing Suncoast Medical Manufacturers, 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.

K841509REPLACE-A-TIP ADJUSTABLE HIGH TEMP.K841604ADJUST-A-TEMP HIGH TEMPERATUREK841459REPLACE-A-TIP ADJUST. LOW TEMP.-K841591PYRO-TIPK840376SURG-A STAT LOOP TIPK840377SURG-A-STAT CARDIOVASCULAR TIP

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Related Devices (Code: GEI)

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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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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