FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PATIENT HEATER SYSTEM, MODEL PH112
K Number: K772015
·
Decision Nov 15, 1977
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
157
Applicant Total
11
Review Days
21
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
- PATIENT HEATER SYSTEM, MODEL PH112
- K Number
- K772015
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5900
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Carolina Medical Electronics
- Date Received
- October 25, 1977
- Decision Date
- November 15, 1977
- 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 Carolina Medical Electronics
| K Number | Device Name | ||
|---|---|---|---|
| K914200 | VASCUMAP MEDICAL AIR PLETHYSMOGRAPH | Nov 7, 1991 | Substantially Equivalent |
| K874684 | TC2-64B TRANSCRANIAL DOPPLER | Apr 25, 1988 | Substantially Equivalent |
| K874685 | TRANS-SCAN 3-D TRANSCRANIAL DOPPLER | Apr 25, 1988 | Substantially Equivalent |
| K864624 | PROBE, UPTAKE, NUCLEAR | Aug 10, 1987 | Substantially Equivalent |
| K843891 | DOPSCAN PLUS DS1060 | Jan 9, 1985 | Substantially Equivalent |
| K837329 | SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUND | Jun 7, 1983 | Substantially Equivalent |
| K820272 | CLINIFLOW II, #701, ELECTROMAGN. BLD. SY | Mar 12, 1982 | Substantially Equivalent |
| K810561 | DOPSCAN MODEL 1050 | Apr 10, 1981 | Substantially Equivalent |
| K801647 | SONACOLOR 6100 | Aug 20, 1980 | Substantially Equivalent |
| K792540 | SONACOLOR 6000 | Jan 17, 1980 | Substantially Equivalent |