BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE)
FDA 510(k) clearance K002565 · decided 2001-05-03
Clearance details
- K-number
- K002565
- Device name
- BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE)
- Applicant
- Baylis Medical Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-08-17
- Decision date
- 2001-05-03
- Days to decision
- 259 days
- Clearance type
- Traditional
- Product code
- GXD
- Device class
- 2
- Regulation number
- 882.4400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mississauga, CA
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.