FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SECHRIST INFANT VENTRILATOR MODEL IV-100
K Number: K811141
·
Decision Jun 12, 1981
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
498
Applicant Total
23
Review Days
46
Basic Information
- Device Name
- SECHRIST INFANT VENTRILATOR MODEL IV-100
- K Number
- K811141
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- SECHRIST INDUSTRIES, INC.
- Date Received
- April 27, 1981
- Decision Date
- June 12, 1981
- 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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