510(k) K901057
K901057 is an FDA 510(k) premarket notification submitted by Spirometrics, Inc. for the device "SPIROMETRICS MODEL 2600 MIRO SPIROMETER". The FDA issued a decision of Substantially Equivalent on April 3, 1990. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Spirometrics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 3, 1990
- Date Received
- March 6, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spirometer, Diagnostic
- Device Class
- Class II
- Regulation Number
- 868.1840
- Review Panel
- AN
- Submission Type