510(k) K935309
K935309 is an FDA 510(k) premarket notification submitted by Acetylene Gas Co. for the device "LUNG DIFFUSION". The FDA issued a decision of Substantially Equivalent on Sep 27, 1994. The device falls under product code BZC (Calculator, Pulmonary Function Data), a Class II device regulated under 21 CFR 868.1880. Acetylene Gas Co. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 27, 1994
- Date Received
- Nov 2, 1993
- 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