510(k) K862286
K862286 is an FDA 510(k) premarket notification submitted by Arthrotek, Inc. for the device "ARTHROPHONOMETER". The FDA issued a decision of Substantially Equivalent on January 7, 1987. The device falls under product code NFQ (Device, Dental Sonography, For Monitoring Jaw Sounds), a Class I device regulated under 21 CFR 872.2050. Arthrotek, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 1987
- Date Received
- June 16, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Dental Sonography, For Monitoring Jaw Sounds
- Device Class
- Class I
- Regulation Number
- 872.2050
- Review Panel
- DE
- Submission Type