FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MADDATHERM PARAFFIN BATH
K Number: K770170
·
Decision Jan 28, 1977
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
11
Applicant Total
6
Review Days
3
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Basic Information
- Device Name
- MADDATHERM PARAFFIN BATH
- K Number
- K770170
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5110
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Techhnilab Instruments, Inc.
- Date Received
- January 25, 1977
- Decision Date
- January 28, 1977
- Product Code
- IMC
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IMC | Bath, Paraffin | FDA class 2 | Physical Medicine |
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Other Clearances by Techhnilab Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K813523 | ELECTRIC SELF STERILIZATION INOCUL. LOOP | Dec 31, 1981 | Substantially Equivalent |
| K780543 | THERMAJUST CIRCU-TEMP | May 26, 1978 | Substantially Equivalent |
| K780544 | DISC-PAK ROTATOR | Apr 24, 1978 | Substantially Equivalent |
| K771434 | MULTI-CAVITY EQUILIBRIUM CELL | Aug 22, 1977 | Substantially Equivalent |
| K770169 | BEESON AUTOMADDAK FEEDER | Jan 28, 1977 | Substantially Equivalent |