FDA 510(k)

PHOTOMETER, SEROMETER (MODEL 380)

K-Number: K760395 · 1976-11-01

Decision Date1976-11-01

Product CodeJJQ

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

PHOTOMETER, SEROMETER (MODEL 380) is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1976-11-01 under 510(k) number K760395. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHOTOMETER, SEROMETER (MODEL 380)?

PHOTOMETER, SEROMETER (MODEL 380) is a medical device that received FDA 510(k) clearance on 1976-11-01. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K760395.

When did PHOTOMETER, SEROMETER (MODEL 380) receive FDA 510(k) clearance?

PHOTOMETER, SEROMETER (MODEL 380) received FDA 510(k) clearance on 1976-11-01, under 510(k) number K760395.

Who is the listed applicant for PHOTOMETER, SEROMETER (MODEL 380)?

The FDA 510(k) record lists Mallinckrodt Critical Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHOTOMETER, SEROMETER (MODEL 380)?

The FDA product code for PHOTOMETER, SEROMETER (MODEL 380) is JJQ.

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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.