FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAGNUM 800(TM) MANAGEMENT SYSTEM
K Number: K881844
·
Decision Jul 14, 1988
Classifications
1
FEI Numbers
228
Registration Numbers
228
Same Product Code
69
Applicant Total
16
Review Days
73
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Basic Information
- Device Name
- MAGNUM 800(TM) MANAGEMENT SYSTEM
- K Number
- K881844
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5100
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- The Medical Group, Inc.
- Date Received
- May 2, 1988
- Decision Date
- July 14, 1988
- Product Code
- FNL
- 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 |
|---|---|---|---|
| FNL | Bed, Ac-Powered Adjustable Hospital | FDA class 2 | General Hospital |
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Other Clearances by The Medical Group, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K911246 | THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2 | Jun 6, 1991 | Substantially Equivalent |
| K901295 | PULMONAIR 40 PATIENT MANAGEMENT SYSTEM | Mar 30, 1990 | Substantially Equivalent |
| K881843 | PEDIATRIC HOSPITAL BED | Oct 26, 1988 | Substantially Equivalent |
| K870282 | 4 X 4 SPONGES, NON-STERILE | Feb 24, 1987 | Substantially Equivalent |
| K870284 | TRIANGULAR BANDAGE | Feb 24, 1987 | Substantially Equivalent |
| K870283 | 3 X 3 SPONGES, NON-STERILE | Feb 24, 1987 | Substantially Equivalent |
| K870285 | THERMOMETER SHEATHES, STERILE (GLASS) | Feb 12, 1987 | Substantially Equivalent |
| K863766 | DISPOSABLE MOUTH MIRRORS, SINGLE USE ONLY | Oct 30, 1986 | Substantially Equivalent |
| K863767 | GLASS MOUTH MIRRORS, REUSABLE | Oct 30, 1986 | Substantially Equivalent |
| K863769 | EVACUATOR TIPS | Oct 30, 1986 | Substantially Equivalent |