510(k) K884329

SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTER by Baxter Healthcare Corp — Product Code DQA

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)

Source: FDA 510(k) database entry for K884329. Report a data issue: hello@regdatalab.com.