510(k) K812778
K812778 is an FDA 510(k) premarket notification submitted by The Telos Co. for the device "THE TELOS EQUIPMENT". The FDA issued a decision of Substantially Equivalent on December 8, 1981. The device falls under product code KQW (Goniometer, Nonpowered), a Class I device regulated under 21 CFR 888.1520. The Telos Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 8, 1981
- Date Received
- October 5, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Goniometer, Nonpowered
- Device Class
- Class I
- Regulation Number
- 888.1520
- Review Panel
- NE
- Submission Type