OXYGEN MASK, AIR-ENTRAINMENT— 510(k) K772127
Substantially EquivalentSalter Labs
FDA 510(k) clearance K772127 for OXYGEN MASK, AIR-ENTRAINMENT, Substantially Equivalent on 1978-01-03. Applicant: Salter Labs. Device class: 1.
Clearance details
- Applicant
- Salter Labs
- Product code
- Code BYF
- Device class
- Class 1
- Regulation
- 21 CFR 868.5600
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.