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FDA 510(k)

RETROFIT BABY FACE SHIELD (RFS)

K-Number: K882291 · 1988-06-20

ApplicantPhysician Engineered Products, Inc.
Decision Date1988-06-20
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RETROFIT BABY FACE SHIELD (RFS) is the device name listed in this FDA 510(k) record. The listed applicant is Physician Engineered Products, Inc.. It received FDA 510(k) clearance on 1988-06-20 under 510(k) number K882291. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RETROFIT BABY FACE SHIELD (RFS)?

RETROFIT BABY FACE SHIELD (RFS) is a medical device that received FDA 510(k) clearance on 1988-06-20. The listed applicant is Physician Engineered Products, Inc.. The 510(k) number is K882291.

When did RETROFIT BABY FACE SHIELD (RFS) receive FDA 510(k) clearance?

RETROFIT BABY FACE SHIELD (RFS) received FDA 510(k) clearance on 1988-06-20, under 510(k) number K882291.

Who is the listed applicant for RETROFIT BABY FACE SHIELD (RFS)?

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

What is the FDA product code for RETROFIT BABY FACE SHIELD (RFS)?

The FDA product code for RETROFIT BABY FACE SHIELD (RFS) is LBI.

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Other records listing Physician Engineered Products, Inc. as applicant

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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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