510(k) K971108
K971108 is an FDA 510(k) premarket notification submitted by Alexander Mfg. Co. for the device "ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS721-P". The FDA issued a decision of Substantially Equivalent on May 6, 1997. The device falls under product code MSG (Ophthalmoscopes, Replacement Batteries, Hand-Held), 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
- May 6, 1997
- Date Received
- March 26, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ophthalmoscopes, Replacement Batteries, Hand-Held
- Device Class
- Class II
- Regulation Number
- 886.1570
- Review Panel
- OP
- Submission Type