510(k) K921306
K921306 is an FDA 510(k) premarket notification submitted by Med Science for the device "ARGIS PULMONARY FUNCTION TESTING SYSTEM". The FDA issued a decision of Substantially Equivalent on June 25, 1993. The device falls under product code BZC (Calculator, Pulmonary Function Data), a Class II device regulated under 21 CFR 868.1880. Med Science has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 25, 1993
- Date Received
- March 18, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calculator, Pulmonary Function Data
- Device Class
- Class II
- Regulation Number
- 868.1880
- Review Panel
- AN
- Submission Type