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FDA 510(k)

AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED

K-Number: K915890 · 1992-06-24

ApplicantPegasus Research Corp.
Decision Date1992-06-24
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Pegasus Research Corp.. It received FDA 510(k) clearance on 1992-06-24 under 510(k) number K915890. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED?

AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED is a medical device that received FDA 510(k) clearance on 1992-06-24. The listed applicant is Pegasus Research Corp.. The 510(k) number is K915890.

When did AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED receive FDA 510(k) clearance?

AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED received FDA 510(k) clearance on 1992-06-24, under 510(k) number K915890.

Who is the listed applicant for AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED?

The FDA 510(k) record lists Pegasus Research Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED?

The FDA product code for AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED is BTT.

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Other records listing Pegasus Research Corp. 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.

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Related Devices (Code: BTT)

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

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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