510(k) K971407
K971407 is an FDA 510(k) premarket notification submitted by J-Tech Medical, Inc. for the device "JTECH COMMANDER AND ALGOMETER". The FDA issued a decision of Substantially Equivalent on April 20, 1998. The device falls under product code HRW (Dynamometer, Nonpowered), a Class I device regulated under 21 CFR 888.1250. J-Tech Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 20, 1998
- Date Received
- April 16, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dynamometer, Nonpowered
- Device Class
- Class I
- Regulation Number
- 888.1250
- Review Panel
- NE
- Submission Type