FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CENTURION-II, MODEL 3103 APNEA/BRADY CARDIA TRACHY
K Number: K851889
·
Decision Oct 23, 1985
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
174
Applicant Total
36
Review Days
176
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Basic Information
- Device Name
- CENTURION-II, MODEL 3103 APNEA/BRADY CARDIA TRACHY
- K Number
- K851889
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Clinical Data, Inc.
- Date Received
- April 30, 1985
- Decision Date
- October 23, 1985
- 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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