510(k) K813619
K813619 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "CONPHAR-SCHIOETZ TONOMETER". The FDA issued a decision of Substantially Equivalent on Feb 24, 1982. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. Conphar, Inc. has 121 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 24, 1982
- Date Received
- Dec 29, 1981
- 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
- 510(k)