FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WIRELESS STANDARD PROBE, DYNAMIC REFERENCE FRAME (DRF)
K Number: K982364
·
Decision Aug 5, 1998
Classifications
1
FEI Numbers
250
Registration Numbers
250
Same Product Code
422
Applicant Total
56
Review Days
30
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Basic Information
- Device Name
- WIRELESS STANDARD PROBE, DYNAMIC REFERENCE FRAME (DRF)
- K Number
- K982364
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radionics, Inc.
- Date Received
- July 6, 1998
- Decision Date
- August 5, 1998
- Product Code
- HAW
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | FDA class 2 | Neurology |
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| K001700 | XPLAN 2.1 | Jun 28, 2000 | Substantially Equivalent |
| K001431 | MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) | May 17, 2000 | Substantially Equivalent |
| K000057 | RADIONICS LUMBOPERITONEAL SHUNT | Mar 20, 2000 | Substantially Equivalent |
| K993594 | CONFORMAX MMLC VR1 | Dec 15, 1999 | Substantially Equivalent |
| K991399 | RADIONICS MICROELECTRODE KIT | Sep 21, 1999 | Substantially Equivalent |