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FDA 510(k)

PORTABLE TRACHEOSTOMY HUMIDIFICATION UNIT

K-Number: K874082 · 1987-12-23

Applicant800-Air-Wats, Inc.
Decision Date1987-12-23
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PORTABLE TRACHEOSTOMY HUMIDIFICATION UNIT is the device name listed in this FDA 510(k) record. The listed applicant is 800-Air-Wats, Inc.. It received FDA 510(k) clearance on 1987-12-23 under 510(k) number K874082. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTABLE TRACHEOSTOMY HUMIDIFICATION UNIT?

PORTABLE TRACHEOSTOMY HUMIDIFICATION UNIT is a medical device that received FDA 510(k) clearance on 1987-12-23. The listed applicant is 800-Air-Wats, Inc.. The 510(k) number is K874082.

When did PORTABLE TRACHEOSTOMY HUMIDIFICATION UNIT receive FDA 510(k) clearance?

PORTABLE TRACHEOSTOMY HUMIDIFICATION UNIT received FDA 510(k) clearance on 1987-12-23, under 510(k) number K874082.

Who is the listed applicant for PORTABLE TRACHEOSTOMY HUMIDIFICATION UNIT?

The FDA 510(k) record lists 800-Air-Wats, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORTABLE TRACHEOSTOMY HUMIDIFICATION UNIT?

The FDA product code for PORTABLE TRACHEOSTOMY HUMIDIFICATION UNIT is CAF.

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Related Devices (Code: CAF)

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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Official Source

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