510(k) K132549
K132549 is an FDA 510(k) premarket notification submitted by Accutome, Inc. for the device "ACCUTIP COVER". The FDA issued a decision of Substantially Equivalent on April 23, 2014. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. Accutome, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 2014
- Date Received
- August 14, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tonometer, Manual
- Device Class
- Class II
- Regulation Number
- 886.1930
- Review Panel
- OP
- Submission Type