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FDA 510(k)

TEMPRA HEAT PACK

K-Number: K951383 · 1995-06-01

ApplicantTempra Technology, Inc.
Decision Date1995-06-01
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

TEMPRA HEAT PACK is the device name listed in this FDA 510(k) record. The listed applicant is Tempra Technology, Inc.. It received FDA 510(k) clearance on 1995-06-01 under 510(k) number K951383. The device is classified under product code IMD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the TEMPRA HEAT PACK?

TEMPRA HEAT PACK is a medical device that received FDA 510(k) clearance on 1995-06-01. The listed applicant is Tempra Technology, Inc.. The 510(k) number is K951383.

When did TEMPRA HEAT PACK receive FDA 510(k) clearance?

TEMPRA HEAT PACK received FDA 510(k) clearance on 1995-06-01, under 510(k) number K951383.

Who is the listed applicant for TEMPRA HEAT PACK?

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

What is the FDA product code for TEMPRA HEAT PACK?

The FDA product code for TEMPRA HEAT PACK is IMD.

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Related Devices (Code: IMD)

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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