FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DECUBITUS MATTRESS
K Number: K760963
·
Decision Nov 18, 1976
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
7
Applicant Total
21
Review Days
14
Basic Information
- Device Name
- DECUBITUS MATTRESS
- K Number
- K760963
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5150
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- ARCO MEDICAL PRODUCTS CO.
- Date Received
- November 4, 1976
- Decision Date
- November 18, 1976
- Product Code
- IKY
- 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 |
|---|---|---|---|
| IKY | Mattress, Flotation Therapy, Non-Powered | FDA class 1 | General Hospital |
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Other Clearances by ARCO MEDICAL PRODUCTS CO.
| K Number | Device Name | ||
|---|---|---|---|
| K802588 | MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN. | Nov 19, 1980 | Substantially Equivalent |
| K801806 | EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE | Sep 9, 1980 | Substantially Equivalent |
| K801241 | UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN. | Jun 30, 1980 | Substantially Equivalent |
| K800837 | PROGRAMMABLE BIPOLAR CARDIAC GENERATOR | Jun 30, 1980 | Substantially Equivalent |
| K800838 | ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN. | Jun 4, 1980 | Substantially Equivalent |
| K800326 | ARCOLITH 3021-CARDIAC PULSE GENERATOR | Mar 17, 1980 | Substantially Equivalent |
| K792216 | ARCOLITH 2100-CARDIAC PULSE GENERATOR | Nov 29, 1979 | Substantially Equivalent |
| K792299 | ARCOLITH 3020-CARDIAC PULSE GENERATOR | Nov 29, 1979 | Substantially Equivalent |
| K791715 | ARCOLITH 2000 | Sep 27, 1979 | Substantially Equivalent |
| K791147 | ARCO PROGAMMABLE PACEMAKER SYSTEM | Aug 3, 1979 | Substantially Equivalent |