Spiroscan 4000
FDA 510(k) K896924 · Brentwood Instruments, Inc.
510(k) numberK896924
Submission
- Device name
- Spiroscan 4000
- Applicant
- Brentwood Instruments, Inc.
Torrange, CA, US - Received
- December 12, 1989
- Decision date
- March 1, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZG – Spirometer, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1840
- Specialty
- Anesthesiology
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Questions and answers
When was Spiroscan 4000 cleared by the FDA?
Spiroscan 4000 (K896924) received a 510(k) decision of Substantially Equivalent on March 1, 1990, 79 days after the submission was received.
What is the product code of K896924?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.