510(k) K874884
K874884 is an FDA 510(k) premarket notification submitted by Metronic, Inc. for the device "MEDTRONIC(R) ORTHOFLEX(TM)". The FDA issued a decision of Substantially Equivalent on January 28, 1988. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380. Metronic, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 28, 1988
- Date Received
- December 1, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Exerciser, Powered
- Device Class
- Class I
- Regulation Number
- 890.5380
- Review Panel
- PM
- Submission Type