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FDA 510(k)

PERSONAL ROMEAR

K-Number: K823588 · 1983-04-27

ApplicantRomear Mfg., Inc.
Decision Date1983-04-27
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PERSONAL ROMEAR is the device name listed in this FDA 510(k) record. The listed applicant is Romear Mfg., Inc.. It received FDA 510(k) clearance on 1983-04-27 under 510(k) number K823588. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERSONAL ROMEAR?

PERSONAL ROMEAR is a medical device that received FDA 510(k) clearance on 1983-04-27. The listed applicant is Romear Mfg., Inc.. The 510(k) number is K823588.

When did PERSONAL ROMEAR receive FDA 510(k) clearance?

PERSONAL ROMEAR received FDA 510(k) clearance on 1983-04-27, under 510(k) number K823588.

Who is the listed applicant for PERSONAL ROMEAR?

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

What is the FDA product code for PERSONAL ROMEAR?

The FDA product code for PERSONAL ROMEAR is ESD.

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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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