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FDA 510(k)

PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS

K-Number: K844176 · 1985-01-23

ApplicantPremie Comfort Products
Decision Date1985-01-23
Product CodeFRP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS is the device name listed in this FDA 510(k) record. The listed applicant is Premie Comfort Products. It received FDA 510(k) clearance on 1985-01-23 under 510(k) number K844176. The device is classified under product code FRP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS?

PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS is a medical device that received FDA 510(k) clearance on 1985-01-23. The listed applicant is Premie Comfort Products. The 510(k) number is K844176.

When did PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS receive FDA 510(k) clearance?

PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS received FDA 510(k) clearance on 1985-01-23, under 510(k) number K844176.

Who is the listed applicant for PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS?

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

What is the FDA product code for PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS?

The FDA product code for PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS is FRP.

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Related Devices (Code: FRP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K082367INFANT SLEEP BEANIELife Innovations, LLCK090284RES-Q INFANT WEDGE AND SLINGCr Enterprises, LLCK062143KOZY COMFORT INFANT POSITIONERAlfred E Mann Inst. For Biomedical EngineeringK060986HEAD BEDSteven H. Warnock, M.D.K051300ROBIN HOOD VESTKamber CorporationK041996NIGHTFORMPlastic Surgery Solutions, LLC

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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