FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARROM CARELIFE SERIES 40000 MODULAR BES SYSTEM
K Number: K854937
·
Decision Feb 4, 1986
Classifications
1
FEI Numbers
228
Registration Numbers
228
Same Product Code
69
Applicant Total
5
Review Days
56
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Basic Information
- Device Name
- CARROM CARELIFE SERIES 40000 MODULAR BES SYSTEM
- K Number
- K854937
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5100
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Carrom Healthcare, Inc.
- Date Received
- December 10, 1985
- Decision Date
- February 4, 1986
- 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 Carrom Healthcare, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K854867 | EVEREST & JENNINGS TRADITION-STANDARD BED L109684& | Feb 4, 1986 | Substantially Equivalent |
| K854832 | EVEREST & JENNING SERIES 5000 MODULAR BED | Feb 4, 1986 | Substantially Equivalent |
| K854776 | EVEREST & JENNINGS BED MODEL NO. L109564 & L108564 | Dec 13, 1985 | Substantially Equivalent |
| K853270 | CENTERCOM CONTROL | Nov 13, 1985 | Substantially Equivalent |