510(k) K860619
- Device
- ES 180-DCM MUSCLE STIMULATOR
- Applicant
- PROMATEK
- 510(k) number
- K860619
- Product code
- IPF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-05-30
- Date received
- 1986-02-19
- Regulation
- 890.5850
- Classification name
- Stimulator, Muscle, Powered
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- ARTHUR LEVINE
- Address
- 8390 Mayrand Montreal, Quebec Canada H4p 2c9 CA
FDA Registration Numbers
- 3003895865
- 3014774380
- 3004081884
- 3004146401
- 3010402752
- 3004264602
- 1528161
- 3012651177
- 3013917867
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- 3005713796
- 3011197543
- 3019055598
- 3030151584
- 3015452693
Source Documents
510(k) summary PDF not indicated by FDA
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Legacy Summary
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FDA Review
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases