510(k) K904777

SERIES 51 AND 53 DISPOSABLE PRESSURE TRANSDUCERS by Baxter Healthcare Corp — Product Code DRS

K904777 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "SERIES 51 AND 53 DISPOSABLE PRESSURE TRANSDUCERS". The FDA issued a decision of Substantially Equivalent on Jan 15, 1991. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Baxter Healthcare Corp has 507 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 15, 1991
Date Received
Oct 22, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Transducer, Blood-Pressure, Extravascular
Device Class
Class II
Regulation Number
870.2850
Review Panel
CV
Submission Type
510(k)

Source: FDA 510(k) database entry for K904777. Report a data issue: hello@regdatalab.com.