510(k) K040188
- Device
- INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE
- Applicant
- Draeger Medical Systems, Inc.
- 510(k) number
- K040188
- Product code
- NHP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-04-14
- Date received
- 2004-01-28
- Regulation
- 868.1500
- Classification name
- Analyzer, Gas, Sevoflurane, Gaseous-phase (anesthetic Concentration)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PENELOPE H GRECO
- Address
- 16 Electronics Ave. Danvers MA US 01923 01923
FDA Registration Numbers#
- 3013557562
- 3003971136
- 3005783425
- 3009077524
- 3013501110
- 9611252
- 3016701404
- 3013500228
- 3010157426
- 3008058135
- 3012528160
- 3000126629
- 3016618143
- 9610816
- 3009831876
- 3009001657
- 2221819
- 1651104
- 3032109181
- 3027256461
- 3008729547
- 3008716327
- 3009499478
- 3013679558
- 9610105
- 3007836437
- 3009156722
- 3013596024
- 3030446844
- 3001570235
- 3004415070
- 3007962724
- 1000122786
- 3004415095
- 3012359877
- 9710602
- 3019388613
- 3003263092
- 3005135175
- 3008483389
- 3011353843
- 3021559257
- 3007603826
- 3005877899
- 8022257
- 9611500
- 2080783
- 1000604079
- 3003589956
- 3008264255
Source Documents#
Legacy Summary#
summary
FDA Review#
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