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FDA 510(k)

AUTOMATED PHYSIOLOGIC PROFILE MONITOR

K-Number: K811560 · 1981-06-18

ApplicantLife Sciences Manufacturing, Inc.
Decision Date1981-06-18
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AUTOMATED PHYSIOLOGIC PROFILE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Life Sciences Manufacturing, Inc.. It received FDA 510(k) clearance on 1981-06-18 under 510(k) number K811560. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOMATED PHYSIOLOGIC PROFILE MONITOR?

AUTOMATED PHYSIOLOGIC PROFILE MONITOR is a medical device that received FDA 510(k) clearance on 1981-06-18. The listed applicant is Life Sciences Manufacturing, Inc.. The 510(k) number is K811560.

When did AUTOMATED PHYSIOLOGIC PROFILE MONITOR receive FDA 510(k) clearance?

AUTOMATED PHYSIOLOGIC PROFILE MONITOR received FDA 510(k) clearance on 1981-06-18, under 510(k) number K811560.

Who is the listed applicant for AUTOMATED PHYSIOLOGIC PROFILE MONITOR?

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

What is the FDA product code for AUTOMATED PHYSIOLOGIC PROFILE MONITOR?

The FDA product code for AUTOMATED PHYSIOLOGIC PROFILE MONITOR is DXG.

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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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