510(k) K895414
K895414 is an FDA 510(k) premarket notification submitted by Integrated Medical Systems, Inc. for the device "MULTIMED (TM) PULMONARY FUNCTION TESTING SYSTEM". The FDA issued a decision of Substantially Equivalent on February 12, 1990. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Integrated Medical Systems, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 1990
- Date Received
- September 1, 1989
- 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