FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ESPREE' BREATHING CIRCUIT (W/ACCESS
K Number: K821311
·
Decision May 21, 1982
Classifications
1
FEI Numbers
199
Registration Numbers
199
Same Product Code
183
Applicant Total
4
Review Days
17
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Basic Information
- Device Name
- ESPREE' BREATHING CIRCUIT (W/ACCESS
- K Number
- K821311
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5240
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Esp Plastics, Inc.
- Date Received
- May 4, 1982
- Decision Date
- May 21, 1982
- 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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