510(k) K023014
- Device
- VIANOX DELIVERY SYSTEM, MODEL I
- Applicant
- PULMONOX MEDICAL, INC.
- 510(k) number
- K023014
- Product code
- MRP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-08-14
- Date received
- 2002-09-10
- Regulation
- 868.2380
- Classification name
- Analyzer, Nitric Oxide
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAULA TOMAT
- Address
- 10835-120th St. Suite 200 Edmonton, Ab CA T5H 3P9 T5H 3P9
FDA Registration Numbers#
- 3012796317
- 2518435
- 3019771924
- 3014527933
- 3004531588
- 1625392
Source Documents#
Legacy Summary#
summary
FDA Review#
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