UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550)
FDA 510(k) clearance K970046 · decided 1997-03-28
Clearance details
- K-number
- K970046
- Device name
- UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550)
- Applicant
- Accutron, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-01-06
- Decision date
- 1997-03-28
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- KHA
- Device class
- 1
- Regulation number
- 868.5590
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Phoenix, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.