FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MTB 1043 TREATMENT BOOTH
K Number: K944133
·
Decision Sep 7, 1995
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
11
Applicant Total
1
Review Days
379
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Basic Information
- Device Name
- MTB 1043 TREATMENT BOOTH
- K Number
- K944133
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5450
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mark Solutions, Inc.
- Date Received
- August 24, 1994
- Decision Date
- September 7, 1995
- 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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