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FDA 510(k)

CRAFTON ARTHROSCOPY PUMP AP-10

K-Number: K823848 · 1983-03-08

ApplicantGambro, Inc.
Decision Date1983-03-08
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CRAFTON ARTHROSCOPY PUMP AP-10 is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1983-03-08 under 510(k) number K823848. 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 CRAFTON ARTHROSCOPY PUMP AP-10?

CRAFTON ARTHROSCOPY PUMP AP-10 is a medical device that received FDA 510(k) clearance on 1983-03-08. The listed applicant is Gambro, Inc.. The 510(k) number is K823848.

When did CRAFTON ARTHROSCOPY PUMP AP-10 receive FDA 510(k) clearance?

CRAFTON ARTHROSCOPY PUMP AP-10 received FDA 510(k) clearance on 1983-03-08, under 510(k) number K823848.

Who is the listed applicant for CRAFTON ARTHROSCOPY PUMP AP-10?

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

What is the FDA product code for CRAFTON ARTHROSCOPY PUMP AP-10?

The FDA product code for CRAFTON ARTHROSCOPY PUMP AP-10 is HRX.

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Other records listing Gambro, Inc. as applicant

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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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