510(k) K843855
- Device
- ERGOTEST 40 & 45
- Applicant
- ERICH JAEGER, INC.
- 510(k) number
- K843855
- Product code
- ISP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-11-27
- Date received
- 1984-10-01
- Regulation
- 890.3420
- Classification name
- Valve, Prosthesis
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3008584163
- 3018070833
- 3022019579
- 1522166
- 2950684
- 3005190268
- 1022826
- 9616494
- 3004737223
- 3022487136
- 3013164247
- 8010401
- 9615102
- 9681133
- 3013742611
- 3004134478
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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