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FDA 510(k)

LOBOW

K-Number: K905250 · 1991-01-08

ApplicantPerinatal Systems
Decision Date1991-01-08
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LOBOW is the device name listed in this FDA 510(k) record. The listed applicant is Perinatal Systems. It received FDA 510(k) clearance on 1991-01-08 under 510(k) number K905250. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOBOW?

LOBOW is a medical device that received FDA 510(k) clearance on 1991-01-08. The listed applicant is Perinatal Systems. The 510(k) number is K905250.

When did LOBOW receive FDA 510(k) clearance?

LOBOW received FDA 510(k) clearance on 1991-01-08, under 510(k) number K905250.

Who is the listed applicant for LOBOW?

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

What is the FDA product code for LOBOW?

The FDA product code for LOBOW is LIT.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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