FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEONATAL BREATHING CIRCUIT MODIFICATION
K Number: K932288
·
Decision Dec 30, 1994
Classifications
1
FEI Numbers
199
Registration Numbers
199
Same Product Code
183
Applicant Total
3
Review Days
599
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Basic Information
- Device Name
- NEONATAL BREATHING CIRCUIT MODIFICATION
- K Number
- K932288
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5240
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Simplex Medical Systems, Inc.
- Date Received
- May 10, 1993
- Decision Date
- December 30, 1994
- Product Code
- CAI
- 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 |
|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | FDA class 1 | Anesthesiology |
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