510(k) K962767
K962767 is an FDA 510(k) premarket notification submitted by Alexander Mfg. Co. for the device "MS401097-17,MS722-K,MS720,MS721,MS722". The FDA issued a decision of Substantially Equivalent on July 3, 1997. The device falls under product code HLJ (Ophthalmoscope, Battery-Powered), a Class II device regulated under 21 CFR 886.1570. Alexander Mfg. Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 1997
- Date Received
- July 16, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ophthalmoscope, Battery-Powered
- Device Class
- Class II
- Regulation Number
- 886.1570
- Review Panel
- OP
- Submission Type