510(k) K953990
K953990 is an FDA 510(k) premarket notification submitted by P.K. Morgan , Ltd. for the device "TRANSFLOW TEST". The FDA issued a decision of Substantially Equivalent on December 9, 1996. The device falls under product code BZC (Calculator, Pulmonary Function Data), a Class II device regulated under 21 CFR 868.1880. P.K. Morgan , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 1996
- Date Received
- August 24, 1995
- 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