510(k) K800939
K800939 is an FDA 510(k) premarket notification submitted by Amf, Inc. for the device "COMPUTRIM 900". The FDA issued a decision of Substantially Equivalent on May 28, 1980. The device falls under product code ISD (Exerciser, Measuring), a Class II device regulated under 21 CFR 890.5360.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 1980
- Date Received
- Apr 22, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Exerciser, Measuring
- Device Class
- Class II
- Regulation Number
- 890.5360
- Review Panel
- PM
- Submission Type
- 510(k) Exempt