FDA 510(k)

MODEL P-8 PROFESSIONAL

K-Number: K811114 · 1981-11-23

Decision Date1981-11-23

Product Code

DecisionSubstantially Equivalent

Device Summary

MODEL P-8 PROFESSIONAL is the device name listed in this FDA 510(k) record. The listed applicant is Bloomex International, Inc.. It received FDA 510(k) clearance on 1981-11-23 under 510(k) number K811114. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL P-8 PROFESSIONAL?

MODEL P-8 PROFESSIONAL is a medical device that received FDA 510(k) clearance on 1981-11-23. The listed applicant is Bloomex International, Inc.. The 510(k) number is K811114.

When did MODEL P-8 PROFESSIONAL receive FDA 510(k) clearance?

MODEL P-8 PROFESSIONAL received FDA 510(k) clearance on 1981-11-23, under 510(k) number K811114.

Who is the listed applicant for MODEL P-8 PROFESSIONAL?

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

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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.