FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR
K Number: K991886
·
Decision May 11, 2000
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
36
Applicant Total
3
Review Days
344
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Basic Information
- Device Name
- PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR
- K Number
- K991886
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1915
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pulsion Medical Systems, Inc.
- Date Received
- June 2, 1999
- Decision Date
- May 11, 2000
- Product Code
- KRB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KRB | Probe, Thermodilution | FDA class 2 | Cardiovascular |
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