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FDA 510(k)

PEEP FACE MASK

K-Number: K801883 · 1980-09-09

ApplicantVital Signs, Inc.
Decision Date1980-09-09
Product CodeBYG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PEEP FACE MASK is the device name listed in this FDA 510(k) record. The listed applicant is Vital Signs, Inc.. It received FDA 510(k) clearance on 1980-09-09 under 510(k) number K801883. The device is classified under product code BYG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEEP FACE MASK?

PEEP FACE MASK is a medical device that received FDA 510(k) clearance on 1980-09-09. The listed applicant is Vital Signs, Inc.. The 510(k) number is K801883.

When did PEEP FACE MASK receive FDA 510(k) clearance?

PEEP FACE MASK received FDA 510(k) clearance on 1980-09-09, under 510(k) number K801883.

Who is the listed applicant for PEEP FACE MASK?

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

What is the FDA product code for PEEP FACE MASK?

The FDA product code for PEEP FACE MASK is BYG.

Other records listing Vital Signs, 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.

K112902ENFLOW IV FLUID WARMERK041309IMASK TMK030985BREAS PV 10I CPAP SYSTEM, MODEL PV 10IK022402DISPOSABLE PRESSURE MANOMETERK021315SURE-LOKK002454BREAS HA50 HUMIDIFIER, MODEL HA50

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Related Devices (Code: BYG)

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.

K963298FIRST AID KIT(S)Vector, Inc.K962848HANS RUDOLPH NASAL CPAP MASKHans Rudolph, Inc.K945482DISPOSABLE, CPAP OXYGEN MASKFvtnksK953464WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASKWestmed, Inc.K953039VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKSDadsun Corp., Ltd.K945472WESTMED PEDIATRIC AND ADULT AEROSOL MASKWestmed Intl.

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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