FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BreatheBand® (Model 1000)
K Number: K250860
·
Decision Oct 2, 2025
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
57
Applicant Total
1
Review Days
195
Basic Information
- Device Name
- BreatheBand® (Model 1000)
- K Number
- K250860
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5665
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Exemplar Medical, LLC
- Date Received
- March 21, 2025
- Decision Date
- October 2, 2025
- Product Code
- BYI
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BYI | Percussor, Powered-Electric | FDA class 2 | Anesthesiology |
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