FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2
K Number: K911246
·
Decision Jun 6, 1991
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
27
Applicant Total
16
Review Days
77
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Basic Information
- Device Name
- THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2
- K Number
- K911246
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5160
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- The Medical Group, Inc.
- Date Received
- March 21, 1991
- Decision Date
- June 6, 1991
- Product Code
- INX
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| INX | Bed, Air Fluidized | FDA class 2 | Physical Medicine |
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Other Clearances by The Medical Group, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K901295 | PULMONAIR 40 PATIENT MANAGEMENT SYSTEM | Mar 30, 1990 | Substantially Equivalent |
| K881843 | PEDIATRIC HOSPITAL BED | Oct 26, 1988 | Substantially Equivalent |
| K881844 | MAGNUM 800(TM) MANAGEMENT SYSTEM | Jul 14, 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 |