510(k) K812001
K812001 is an FDA 510(k) premarket notification submitted by Jones Medical Instrument Co. for the device "OSCILLAIRE". The FDA issued a decision of Substantially Equivalent on Aug 20, 1981. The device falls under product code BZC (Calculator, Pulmonary Function Data), a Class II device regulated under 21 CFR 868.1880. Jones Medical Instrument Co. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 20, 1981
- Date Received
- Jul 14, 1981
- 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
- 510(k)