510(k) K040580
- Device
- AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR
- Applicant
- D.Y. INSTRUMENT, INC.
- 510(k) number
- K040580
- Product code
- NRW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-08-26
- Date received
- 2004-03-04
- Regulation
- 880.5580
- Classification name
- Stimulator, Intramuscular, Automatic
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- ANNA D LEE
- Address
- 30 Manning Ln. Cherry Hill NJ US 08003 08003
Source Documents
Legacy Summary
summary
FDA Review
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