510(k) K962532
K962532 is an FDA 510(k) premarket notification submitted by Expertech Assoc., Inc. for the device "RODENSTOCK SLITLAMP (MODEL 5000 & 4000)". The FDA issued a decision of Substantially Equivalent on July 25, 1996. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Expertech Assoc., Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 1996
- Date Received
- June 28, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biomicroscope, Slit-Lamp, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1850
- Review Panel
- OP
- Submission Type