510(k) K971827
K971827 is an FDA 510(k) premarket notification submitted by Alexander Mfg. Co. for the device "ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS71764". The FDA issued a decision of Substantially Equivalent on August 12, 1997. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Alexander Mfg. Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 1997
- Date Received
- May 16, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oximeter
- Device Class
- Class II
- Regulation Number
- 870.2700
- Review Panel
- AN
- Submission Type