AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR
FDA 510(k) clearance K040580 · decided 2004-08-26
Clearance details
- K-number
- K040580
- Device name
- AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR
- Applicant
- D.Y. Instrument, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-03-04
- Decision date
- 2004-08-26
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- NRW
- Device class
- 2
- Regulation number
- 880.5580
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Cherry Hill, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.