510(k) K973850
K973850 is an FDA 510(k) premarket notification submitted by Alexander Mfg. Co. for the device "ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007". The FDA issued a decision of Substantially Equivalent on November 12, 1997. The device falls under product code HFO (Recorder, Pressure, Intrauterine), a Class II device regulated under 21 CFR 884.2700. Alexander Mfg. Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 1997
- Date Received
- October 8, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Recorder, Pressure, Intrauterine
- Device Class
- Class II
- Regulation Number
- 884.2700
- Review Panel
- OB
- Submission Type