510(k) K884329
K884329 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTER". The FDA issued a decision of Substantially Equivalent on Dec 16, 1988. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 16, 1988
- Date Received
- Oct 14, 1988
- 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
- 510(k)