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FDA 510(k)

AMR MINI-LAPAROSCOPE

K-Number: K962777 · 1997-08-06

ApplicantApplied Medical Resources
Decision Date1997-08-06
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AMR MINI-LAPAROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources. It received FDA 510(k) clearance on 1997-08-06 under 510(k) number K962777. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMR MINI-LAPAROSCOPE?

AMR MINI-LAPAROSCOPE is a medical device that received FDA 510(k) clearance on 1997-08-06. The listed applicant is Applied Medical Resources. The 510(k) number is K962777.

When did AMR MINI-LAPAROSCOPE receive FDA 510(k) clearance?

AMR MINI-LAPAROSCOPE received FDA 510(k) clearance on 1997-08-06, under 510(k) number K962777.

Who is the listed applicant for AMR MINI-LAPAROSCOPE?

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

What is the FDA product code for AMR MINI-LAPAROSCOPE?

The FDA product code for AMR MINI-LAPAROSCOPE is HET.

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Other records listing Applied Medical Resources as applicant

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Related Devices (Code: HET)

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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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