510(k) K954730
K954730 is an FDA 510(k) premarket notification submitted by P.K. Morgan , Ltd. for the device "BENCHMARK TRANSFER TEST". The FDA issued a decision of Substantially Equivalent on April 1, 1997. 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
- April 1, 1997
- Date Received
- October 16, 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