FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OEM MEDICAL ADULT ANESTHESIA BREATHING CIRCUIT
K Number: K925893
·
Decision Mar 12, 1993
Classifications
1
FEI Numbers
199
Registration Numbers
199
Same Product Code
183
Applicant Total
5
Review Days
115
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Basic Information
- Device Name
- OEM MEDICAL ADULT ANESTHESIA BREATHING CIRCUIT
- K Number
- K925893
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5240
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Oem Medical Div.
- Date Received
- November 17, 1992
- Decision Date
- March 12, 1993
- 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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