FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUTOVAC BP SYSTE, 2000 SERIES
K Number: K955010
·
Decision Jun 20, 1996
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
194
Applicant Total
38
Review Days
232
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Basic Information
- Device Name
- AUTOVAC BP SYSTE, 2000 SERIES
- K Number
- K955010
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5830
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Boehringer Laboratories
- Date Received
- November 1, 1995
- Decision Date
- June 20, 1996
- Product Code
- CAC
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAC | Apparatus, Autotransfusion | FDA class 2 | Anesthesiology |
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