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FDA 510(k)

BURLEW INFANT HOOD

K-Number: K962182 · 1996-07-15

ApplicantPromedic, Inc.
Decision Date1996-07-15
Product CodeFOG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BURLEW INFANT HOOD is the device name listed in this FDA 510(k) record. The listed applicant is Promedic, Inc.. It received FDA 510(k) clearance on 1996-07-15 under 510(k) number K962182. The device is classified under product code FOG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BURLEW INFANT HOOD?

BURLEW INFANT HOOD is a medical device that received FDA 510(k) clearance on 1996-07-15. The listed applicant is Promedic, Inc.. The 510(k) number is K962182.

When did BURLEW INFANT HOOD receive FDA 510(k) clearance?

BURLEW INFANT HOOD received FDA 510(k) clearance on 1996-07-15, under 510(k) number K962182.

Who is the listed applicant for BURLEW INFANT HOOD?

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

What is the FDA product code for BURLEW INFANT HOOD?

The FDA product code for BURLEW INFANT HOOD is FOG.

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Other records listing Promedic, Inc. as applicant

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.

K112318CLEARPATH 24K072756NON-IV ADAPTER FOR INFANT NG TUBEK060497BABYAIRK060842REVJET TURBOK052903PEDIATRIC FEEDING TUBEK031409URINARY CATHETERS

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Related Devices (Code: FOG)

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.

K973128OLYMPUS NA-10J-1 ASPIRATION NEEDLEOlympus America, Inc.K955482SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION)Advantage Medical Services, Inc.K830781ENDO-GUARDJayco PharmaceuticalsK792144DISPOSA-HOODUtah Medical Products, Inc.K791861OXYGEN HOODSAnn Arbor Plastics, Inc.K790860RT-HOODPlastics Supplies & Products

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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