510(k) K980224
K980224 is an FDA 510(k) premarket notification submitted by Alexander Mfg. Co. for the device "ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822". The FDA issued a decision of Substantially Equivalent on April 2, 1998. The device falls under product code MOQ (Battery, Replacement, Rechargeable), a Class I device regulated under 21 CFR 878.4820. Alexander Mfg. Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 2, 1998
- Date Received
- January 22, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Battery, Replacement, Rechargeable
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- SU
- Submission Type