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FDA 510(k)

THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000

K-Number: K903489 · 1990-12-10

ApplicantPegasus Research Corp.
Decision Date1990-12-10
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000 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 1990-12-10 under 510(k) number K903489. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000?

THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000 is a medical device that received FDA 510(k) clearance on 1990-12-10. The listed applicant is Pegasus Research Corp.. The 510(k) number is K903489.

When did THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000 receive FDA 510(k) clearance?

THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000 received FDA 510(k) clearance on 1990-12-10, under 510(k) number K903489.

Who is the listed applicant for THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000?

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 THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000?

The FDA product code for THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000 is BWF.

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Other records listing Pegasus Research Corp. as applicant

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Related Devices (Code: BWF)

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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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