510(k) K800547
K800547 is an FDA 510(k) premarket notification submitted by Cybermedic, Inc. for the device "MEDISTOR III LUNG ANALYZER". The FDA issued a decision of Substantially Equivalent on March 25, 1980. The device falls under product code BZC (Calculator, Pulmonary Function Data), a Class II device regulated under 21 CFR 868.1880. Cybermedic, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 25, 1980
- Date Received
- March 10, 1980
- 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