FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDI-THERM
K Number: K800812
·
Decision Apr 24, 1980
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
157
Applicant Total
27
Review Days
13
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MEDI-THERM
- K Number
- K800812
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5900
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Gaymar Industries, Inc.
- Date Received
- April 11, 1980
- Decision Date
- April 24, 1980
- Product Code
- DWJ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DWJ | System, Thermal Regulating | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DWJ), ordered by most recent decision date.
Hot Pink Pad Warming System
FDA 510(k)
FDA Class 2
·Cardiovascular
Warming System
FDA 510(k)
FDA Class 2
·Cardiovascular
Arctic Sun Temperature Management System (Model 5000)
FDA 510(k)
FDA Class 2
·Cardiovascular
Celsi Warmer
FDA 510(k)
FDA Class 2
·Cardiovascular
Arctic Sun Stat Temperature Management System
FDA 510(k)
FDA Class 2
·Cardiovascular
HotDog Warming Mattress + Return Electrode
FDA 510(k)
FDA Class 2
·Cardiovascular
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 |
| K914921 | SCM-3 AND ACCESSORIES | Mar 12, 1992 | Substantially Equivalent |
| K914805 | TC-1000, TC-1050 SYSTEM | Jan 7, 1992 | Substantially Equivalent |
| K914851 | CLA-1400 SYSTEM | Nov 13, 1991 | Substantially Equivalent |