FDA 510(k)
FDA class 2
Substantially Equivalent - Subject to Tracking Reg.
🇺🇸 United States
PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION
K Number: K021573
·
Decision Aug 13, 2002
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
504
Applicant Total
4
Review Days
91
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Basic Information
- Device Name
- PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION
- K Number
- K021573
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Applicant
- Puritan-Bennett
- Date Received
- May 14, 2002
- Decision Date
- August 13, 2002
- Product Code
- CBK
- 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | FDA class 2 | Anesthesiology |
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