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FDA 510(k)

NON REBREATHING MASK

K-Number: K913164 · 1992-01-15

ApplicantSpecialty Packaging Producs, Inc.
Decision Date1992-01-15
Product CodeKGB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NON REBREATHING MASK is the device name listed in this FDA 510(k) record. The listed applicant is Specialty Packaging Producs, Inc.. It received FDA 510(k) clearance on 1992-01-15 under 510(k) number K913164. The device is classified under product code KGB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NON REBREATHING MASK?

NON REBREATHING MASK is a medical device that received FDA 510(k) clearance on 1992-01-15. The listed applicant is Specialty Packaging Producs, Inc.. The 510(k) number is K913164.

When did NON REBREATHING MASK receive FDA 510(k) clearance?

NON REBREATHING MASK received FDA 510(k) clearance on 1992-01-15, under 510(k) number K913164.

Who is the listed applicant for NON REBREATHING MASK?

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

What is the FDA product code for NON REBREATHING MASK?

The FDA product code for NON REBREATHING MASK is KGB.

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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.

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Other records listing Specialty Packaging Producs, 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.

K922492SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTERK913163NON REBREATHING VALVEK913422OXYGEN TUBING, 81503K913216TRACH T ADAPTERK913383OXYGEN MASKS 81420, 81421, 81471 & 81461K913421NASAL OXYGEN CANNULA, 81585, 81587 & 81589

View all 11 devices →

Related Devices (Code: KGB)

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.

K970688POCKET RESCUECheen Houng Ent. Co. , Ltd.K960401ULTIMATE SEALHans Rudolph, Inc.K941336COMBO MASKGam Industries, Inc.K935917CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVESBd Becton Dickinson Vacutainer Systems PreanalyticK932347COMPACT MASKVital Signs, Inc.K933583NONREBREATHING VALVEHans Rudolph, Inc.

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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