FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KETRONIC MEDAX - N
K Number: K843288
·
Decision Nov 8, 1984
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
129
Applicant Total
10
Review Days
79
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Basic Information
- Device Name
- KETRONIC MEDAX - N
- K Number
- K843288
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1100
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Ketronic, Inc.
- Date Received
- August 21, 1984
- Decision Date
- November 8, 1984
- Product Code
- IYX
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IYX | Camera, Scintillation (Gamma) | FDA class 1 | Radiology |
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Other Clearances by Ketronic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K850877 | MONOLIFT MPE2, PLATFORM, CHAIR, FULLY FUTO PLATFOR | Jun 12, 1985 | Substantially Equivalent |
| K850873 | HILO TABLES, TYPE CH-4, CH-8, FW-6, FW-5, FW-2, AL | Jun 12, 1985 | Substantially Equivalent |
| K850870 | MEDIFETTE ERGOMETER | Jun 12, 1985 | Substantially Equivalent |
| K850868 | MFE CARDIAC STRESS SYSTEM | Jun 12, 1985 | Substantially Equivalent |
| K850869 | MFE COUCH ERGOMETER | Jun 12, 1985 | Substantially Equivalent |
| K850872 | PHYACTION 300, 360, 370, 390 & 391 ELEC-MUSCLE-STI | Jun 6, 1985 | Substantially Equivalent for Some Indications |
| K850871 | TREDBAND TYPE I, IT, II & III - TREADMILLS | Jun 5, 1985 | Substantially Equivalent |
| K850876 | LIGTVOET L80.2 LIGHTFOOT L80.2 POWER WHEELCHAIR | May 16, 1985 | Substantially Equivalent |
| K850875 | ACTION-WHEELS & PLAY WHEELS | May 16, 1985 | Substantially Equivalent |