Somniprobe II Nasal and Buccal Airflow Mon. Syst.

FDA 510(k) K904118 · Dawn Medical

Substantially Equivalent

510(k) numberK904118

Submission

Device name
Somniprobe II Nasal and Buccal Airflow Mon. Syst.
Applicant
Dawn Medical
San Francisco, CA, US
Received
September 6, 1990
Decision date
February 25, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BZG – Spirometer, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1840
Specialty
Anesthesiology

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More from Vitalograph Ireland, Ltd.

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K933135Dawn Disposable Biopsy ForcepsFCL · Traditional 03/07/1994SE
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Questions and answers

When was Somniprobe II Nasal and Buccal Airflow Mon. Syst. cleared by the FDA?

Somniprobe II Nasal and Buccal Airflow Mon. Syst. (K904118) received a 510(k) decision of Substantially Equivalent on February 25, 1991, 172 days after the submission was received.

What is the product code of K904118?

The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.