510(k) K092625
- Device
- WAVESTATE NEUROMONITOR
- Applicant
- WAVESTATE INC
- 510(k) number
- K092625
- Product code
- ORT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-06-29
- Date received
- 2009-08-27
- Regulation
- 882.1400
- Classification name
- Burst Suppression Detection Software For Electroencephalograph
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- E.J. Smith
- Address
- 1468 Harwell Ave. Crofton MD US 21114 21114
FDA Registration Numbers#
- 9612330
- 3004762958
- 3005783425
- 9612389
- 8030229
- 3009247326
- 3009077524
- 8044004
- 3013501110
- 9611252
- 3024892936
- 3016701404
- 3013500228
- 3010157426
- 3000126629
- 3012528160
- 3008657519
- 3008202779
- 9610816
- 3009831876
- 2221819
- 1651104
- 3032109181
- 3027256461
- 3008729547
- 3016674095
- 3010611950
- 3013679558
- 9610105
- 3009156722
- 3013596024
- 3001570235
- 3004415095
- 3012359877
- 9710602
- 3019388613
- 3003263092
- 3008483389
- 3011353843
- 3007603826
- 3005581270
- 3038281851
- 3005877899
- 8022257
- 3014461810
- 3016852448
- 2080783
Source Documents#
Legacy Summary#
summary
FDA Review#
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