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FDA 510(k)

BIOPHOTAS CELLUMA3

K-Number: K171323 · 2017-09-01

ApplicantBiophotas, Inc.
Decision Date2017-09-01
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIOPHOTAS CELLUMA3 is a medical device manufactured by Biophotas, Inc.. It received FDA 510(k) clearance on 2017-09-01 under approval number K171323. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPHOTAS CELLUMA3?

BIOPHOTAS CELLUMA3 is a medical device that received FDA 510(k) clearance on 2017-09-01. It is manufactured by Biophotas, Inc.. The 510(k) number is K171323.

When was BIOPHOTAS CELLUMA3 approved by the FDA?

BIOPHOTAS CELLUMA3 received FDA 510(k) clearance on 2017-09-01, under approval number K171323.

What company makes BIOPHOTAS CELLUMA3?

BIOPHOTAS CELLUMA3 is manufactured by Biophotas, Inc..

What is the FDA product code for BIOPHOTAS CELLUMA3?

The FDA product code for BIOPHOTAS CELLUMA3 is OHS.

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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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