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FDA 510(k)

MODEL 57000 NASO-CONJUNCTIVA ISOL. MASK

K-Number: K822125 · 1982-08-27

ApplicantWelch Allyn, Inc.
Decision Date1982-08-27
Product Code
DecisionSubstantially Equivalent

Device Summary

MODEL 57000 NASO-CONJUNCTIVA ISOL. MASK is the device name listed in this FDA 510(k) record. The listed applicant is Welch Allyn, Inc.. It received FDA 510(k) clearance on 1982-08-27 under 510(k) number K822125. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 57000 NASO-CONJUNCTIVA ISOL. MASK?

MODEL 57000 NASO-CONJUNCTIVA ISOL. MASK is a medical device that received FDA 510(k) clearance on 1982-08-27. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K822125.

When did MODEL 57000 NASO-CONJUNCTIVA ISOL. MASK receive FDA 510(k) clearance?

MODEL 57000 NASO-CONJUNCTIVA ISOL. MASK received FDA 510(k) clearance on 1982-08-27, under 510(k) number K822125.

Who is the listed applicant for MODEL 57000 NASO-CONJUNCTIVA ISOL. MASK?

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

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Other records listing Welch Allyn, 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.

K243598Welch Allyn Connex® 360 (Multiple)K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)K223381iExaminer System with Panoptic PlusK212473Welch Allyn Connex Central StationK191013Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionK181016Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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