FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SCM-3 AND ACCESSORIES
K Number: K914921
·
Decision Mar 12, 1992
Classifications
1
FEI Numbers
154
Registration Numbers
154
Same Product Code
7
Applicant Total
27
Review Days
129
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Basic Information
- Device Name
- SCM-3 AND ACCESSORIES
- K Number
- K914921
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5150
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gaymar Industries, Inc.
- Date Received
- November 4, 1991
- Decision Date
- March 12, 1992
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IKY), ordered by most recent decision date.
GEL FLOTATION MATTRESS
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BEDDING PADS EGGCREATE PADS
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TETRA NATAL-MAT WATER FLOTATION MAT.
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ECONO-FLOAT WATER FLOTATION MATTRESS
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NEONATAL FLOTATION SYSTEM
FDA 510(k)
FDA Class 1
·General Hospital
MEDPRO FLOTATION SYSTEM
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Gaymar Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K100585 | MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 | Jan 20, 2011 | Substantially Equivalent |
| K073675 | T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP | May 8, 2008 | Substantially Equivalent |
| K962788 | CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM | Apr 30, 1997 | Substantially Equivalent |
| K963067 | SOF. PRESS EPC 51 SYSTEM | Jan 28, 1997 | Substantially Equivalent |
| K961854 | SPR PLUS II OVERLAY SYSTEM (CL250/CL212 | Aug 9, 1996 | Substantially Equivalent |
| K942881 | TC 3000 | May 23, 1995 | Substantially Equivalent |
| K930345 | TC2000 POWER UNIT AND ACCESSORIES | Aug 6, 1993 | Substantially Equivalent |
| K914805 | TC-1000, TC-1050 SYSTEM | Jan 7, 1992 | Substantially Equivalent |
| K914851 | CLA-1400 SYSTEM | Nov 13, 1991 | Substantially Equivalent |
| K912051 | MEDI-THERM (MTA-5900) & DETACHABLE HOSES | Jul 30, 1991 | Substantially Equivalent |