FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BODAI NEO2 -SAFE AIRWAY PRESSURE CAP
K Number: K913753
·
Decision Oct 23, 1991
Classifications
1
FEI Numbers
199
Registration Numbers
199
Same Product Code
183
Applicant Total
23
Review Days
63
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Basic Information
- Device Name
- BODAI NEO2 -SAFE AIRWAY PRESSURE CAP
- K Number
- K913753
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5240
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- B&B Medical Technologies, Inc.
- Date Received
- August 21, 1991
- Decision Date
- October 23, 1991
- 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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| K945816 | QUICK-LOCK | Jan 13, 1995 | Substantially Equivalent |
| K944324 | SURE-LOCK VENTILATOR TUBING HOLDER | Nov 4, 1994 | Substantially Equivalent |
| K935171 | STABILTRACH | Dec 2, 1993 | Substantially Equivalent |
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| K923690 | MINI HEART | Oct 20, 1992 | Substantially Equivalent |
| K913015 | HEART NEBULIZER FLOWMETER ADAPTOR | Nov 20, 1991 | Substantially Equivalent |
| K913000 | HEART NEBULIZER POLE CLAMP | Aug 2, 1991 | Substantially Equivalent |