FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504
K Number: K982225
·
Decision Oct 28, 1998
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
99
Applicant Total
4
Review Days
126
Basic Information
- Device Name
- SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504
- K Number
- K982225
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5925
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SPIRACLE TECHNOLOGY
- Date Received
- June 24, 1998
- Decision Date
- October 28, 1998
- Product Code
- BTL
- 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 |
|---|---|---|---|
| BTL | Ventilator, Emergency, Powered (Resuscitator) | FDA class 2 | Anesthesiology |
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