FDA 510(k) Premarket Notification K945777: PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES

Submission Details & Decision

Normalized public record details for 510(k) notification K945777.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K945777

Applicant / Sponsor

Smiths Industries Medical Systems, Inc.

Device Name

PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES

Product Code

JKA

Decision Date

1994-12-22

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

1994-11-25

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