FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRETCHER TRANSIT ISOLATER #122
K Number: K790657
·
Decision Jul 3, 1979
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
11
Applicant Total
22
Review Days
89
Basic Information
- Device Name
- STRETCHER TRANSIT ISOLATER #122
- K Number
- K790657
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5450
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- VICKERS AMERICA MEDICAL CORP.
- Date Received
- April 5, 1979
- Decision Date
- July 3, 1979
- Product Code
- LGM
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LGM | Chamber, Patient Isolation | FDA class 2 | General Hospital |
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