510(k) K972084
K972084 is an FDA 510(k) premarket notification submitted by Alexander Mfg. Co. for the device "ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212". The FDA issued a decision of Substantially Equivalent on Jul 3, 1997. The device falls under product code FLN (Monitor, Electric For Gravity Flow Infusion Systems), a Class II device regulated under 21 CFR 880.2420. Alexander Mfg. Co. has 38 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 3, 1997
- Date Received
- Jun 4, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Monitor, Electric For Gravity Flow Infusion Systems
- Device Class
- Class II
- Regulation Number
- 880.2420
- Review Panel
- HO
- Submission Type
- 510(k)