PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR— 510(k) K991886

Clearance details

Applicant

Pulsion Medical Systems, Inc.

Product code

Code KRB

Device class

Class 2

Regulation

21 CFR 870.1915

Advisory panel

Cardiovascular

Date received

1999-06-02

Decision date

2000-05-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Wilmington, NC, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K991886.