FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PEDIATRIC HOSPITAL BED
K Number: K881843
·
Decision Oct 26, 1988
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
56
Applicant Total
16
Review Days
177
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Basic Information
- Device Name
- PEDIATRIC HOSPITAL BED
- K Number
- K881843
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5170
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- The Medical Group, Inc.
- Date Received
- May 2, 1988
- Decision Date
- October 26, 1988
- Product Code
- IOQ
- 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 |
|---|---|---|---|
| IOQ | Bed, Flotation Therapy, Powered | FDA class 2 | Physical Medicine |
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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 |
| 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 |