510(k) K082829
- Device
- AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS)
- Applicant
- CARLETON LIFE SUPPORT SYSTEMS INC.
- 510(k) number
- K082829
- Product code
- OLF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-12-22
- Date received
- 2008-09-25
- Regulation
- 868.5440
- Classification name
- Medevac Use Oxygen Generator
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
- Expedited review
- Y
Applicant Contact#
- Contact
- GARY BYRD
- Address
- 2734 Hickory Grove Rd. Davenport IA US 52804 52804
FDA Registration Numbers#
- 3002840531
Source Documents#
Legacy Summary#
summary
FDA Review#
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