Breezing Med
FDA 510(k) clearance K200076 · decided 2020-09-25
Clearance details
- K-number
- K200076
- Device name
- Breezing Med
- Applicant
- Tf Health Co.
- Decision
- Substantially Equivalent
- Date received
- 2020-01-14
- Decision date
- 2020-09-25
- Days to decision
- 255 days
- Clearance type
- Traditional
- Product code
- BZL
- Device class
- 2
- Regulation number
- 868.1730
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Tempe, AZ, US
- Third-party review
- No
- Expedited review
- No
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| OXYLOG 2 (K954731) | P.K. Morgan , Ltd. | 1997-01-06 |
| 7250 METABOLIC MONITOR (K924978) | Puritan Bennett Corp. | 1994-09-22 |
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Recalls involving this device
No recalls on record reference this clearance.