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FDA 510(k)

ACUMED CARPAL TUNNEL RELEASE KIT

K-Number: K933638 · 1994-03-24

ApplicantAcu Med, Inc.
Decision Date1994-03-24
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUMED CARPAL TUNNEL RELEASE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Acu Med, Inc.. It received FDA 510(k) clearance on 1994-03-24 under 510(k) number K933638. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUMED CARPAL TUNNEL RELEASE KIT?

ACUMED CARPAL TUNNEL RELEASE KIT is a medical device that received FDA 510(k) clearance on 1994-03-24. The listed applicant is Acu Med, Inc.. The 510(k) number is K933638.

When did ACUMED CARPAL TUNNEL RELEASE KIT receive FDA 510(k) clearance?

ACUMED CARPAL TUNNEL RELEASE KIT received FDA 510(k) clearance on 1994-03-24, under 510(k) number K933638.

Who is the listed applicant for ACUMED CARPAL TUNNEL RELEASE KIT?

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

What is the FDA product code for ACUMED CARPAL TUNNEL RELEASE KIT?

The FDA product code for ACUMED CARPAL TUNNEL RELEASE KIT is HRX.

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Other records listing Acu Med, Inc. as applicant

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Related Devices (Code: HRX)

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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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