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FDA 510(k)

CAREPAK

K-Number: K942350 · 1994-12-06

ApplicantPrecision Medical, Inc.
Decision Date1994-12-06
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CAREPAK is the device name listed in this FDA 510(k) record. The listed applicant is Precision Medical, Inc.. It received FDA 510(k) clearance on 1994-12-06 under 510(k) number K942350. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAREPAK?

CAREPAK is a medical device that received FDA 510(k) clearance on 1994-12-06. The listed applicant is Precision Medical, Inc.. The 510(k) number is K942350.

When did CAREPAK receive FDA 510(k) clearance?

CAREPAK received FDA 510(k) clearance on 1994-12-06, under 510(k) number K942350.

Who is the listed applicant for CAREPAK?

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

What is the FDA product code for CAREPAK?

The FDA product code for CAREPAK is CAF.

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Other records listing Precision Medical, Inc. as applicant

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Related Devices (Code: CAF)

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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