PALI-TRODE
FDA 510(k) clearance K981015 · decided 1998-06-16
Clearance details
- K-number
- K981015
- Device name
- PALI-TRODE
- Applicant
- Preferred Instruments
- Decision
- Substantially Equivalent
- Date received
- 1998-03-18
- Decision date
- 1998-06-16
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- GZL
- Device class
- 2
- Regulation number
- 882.1330
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Downers Grove, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.