510(k) K893470
K893470 is an FDA 510(k) premarket notification submitted by Siemens Medical Electronics for the device "SIEMENS SAO2 + PULS OXIMETRY CARTRIDGE". The FDA issued a decision of Substantially Equivalent on August 3, 1989. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Siemens Medical Electronics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 3, 1989
- Date Received
- May 4, 1989
- 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