FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS
K Number: K022260
·
Decision Aug 29, 2002
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
11
Applicant Total
1
Review Days
62
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Basic Information
- Device Name
- FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS
- K Number
- K022260
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5450
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Isolation Systems, Inc.
- Date Received
- June 28, 2002
- Decision Date
- August 29, 2002
- 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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