510(k) K091963
- Device
- VIGILANT EEG MONITOR, VIGILANT 2.0
- Applicant
- INFINITE BIOMEDICAL TECHNOLOGIES, LLC
- 510(k) number
- K091963
- Product code
- OLT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-11-06
- Date received
- 2009-07-01
- Regulation
- 882.1400
- Classification name
- Non-normalizing Quantitative Electroencephalograph Software
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MANAN HATHI
- Address
- 3600 Clipper Mill Rd. Suite 410 Baltimore MD US 21211 21211
FDA Registration Numbers#
- 9612330
- 9617286
- 3004762958
- 3011184129
- 3005783425
- 8030229
- 3009247326
- 3009077524
- 3010900508
- 3005713796
- 8044004
- 3013501110
- 9611252
- 3024892936
- 3008008477
- 3016701404
- 3013500228
- 3015929663
- 3010157426
- 3000126629
- 3012528160
- 3008657519
- 2031720
- 3007048291
- 9610816
- 3009831876
- 3010536822
- 3017374042
- 2221819
- 3011047165
- 1651104
- 3008881376
- 1063925
- 3032109181
- 3027256461
- 3008729547
- 3016674095
- 3001687738
- 3010611950
- 3013679558
- 9610105
- 3009156722
- 3013596024
- 3001570235
- 3004415095
- 3007962724
- 3012359877
- 9710602
- 3019388613
- 2023374
- 3004203820
- 3008483389
- 3011353843
- 3020018
- 3007603826
- 3005581270
- 3017666517
- 3038281851
- 2184161
- 3005877899
- 3006418479
- 3007611554
- 8022257
- 3014461810
- 3016852448
- 3008773490
- 2080783
- 3012182497
Source Documents#
Legacy Summary#
summary
FDA Review#
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