FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522
K Number: K982216
·
Decision Sep 11, 1998
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
171
Applicant Total
8
Review Days
80
Basic Information
- Device Name
- ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522
- K Number
- K982216
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- BRAEBON MEDICAL CORP.
- Date Received
- June 23, 1998
- Decision Date
- September 11, 1998
- Product Code
- BZQ
- 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 |
|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | FDA class 2 | Anesthesiology |
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