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FDA 510(k)

JEMSDAL MASK

K-Number: K942907 · 1994-08-31

ApplicantRespan Products, Inc.
Decision Date1994-08-31
Product CodeBYG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

JEMSDAL MASK is the device name listed in this FDA 510(k) record. The listed applicant is Respan Products, Inc.. It received FDA 510(k) clearance on 1994-08-31 under 510(k) number K942907. 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 JEMSDAL MASK?

JEMSDAL MASK is a medical device that received FDA 510(k) clearance on 1994-08-31. The listed applicant is Respan Products, Inc.. The 510(k) number is K942907.

When did JEMSDAL MASK receive FDA 510(k) clearance?

JEMSDAL MASK received FDA 510(k) clearance on 1994-08-31, under 510(k) number K942907.

Who is the listed applicant for JEMSDAL MASK?

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

What is the FDA product code for JEMSDAL MASK?

The FDA product code for JEMSDAL MASK is BYG.

Related Clinical Trials

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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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