510(k) K083377
K083377 is an FDA 510(k) premarket notification submitted by Accutome Ultrasound, Inc. for the device "ACCUPEN". The FDA issued a decision of Substantially Equivalent on July 27, 2009. The device falls under product code HKX (Tonometer, Ac-Powered), a Class II device regulated under 21 CFR 886.1930. Accutome Ultrasound, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 2009
- Date Received
- November 14, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tonometer, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1930
- Review Panel
- OP
- Submission Type