510(k) K946322
K946322 is an FDA 510(k) premarket notification submitted by Synectics Medical, Inc. for the device "POLYGRAM SOFTWARE". The FDA issued a decision of Substantially Equivalent on July 7, 1995. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Synectics Medical, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 7, 1995
- Date Received
- December 28, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spirometer, Diagnostic
- Device Class
- Class II
- Regulation Number
- 868.1840
- Review Panel
- AN
- Submission Type