FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENTRAPPING FILTER
K Number: K896116
·
Decision Nov 17, 1989
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
201
Applicant Total
6
Review Days
28
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Basic Information
- Device Name
- ENTRAPPING FILTER
- K Number
- K896116
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5260
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Cadema Medical Products, Inc.
- Date Received
- October 20, 1989
- Decision Date
- November 17, 1989
- Product Code
- CAH
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | FDA class 2 | Anesthesiology |
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Other Clearances by Cadema Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K901476 | MODIFIED ENTRAPPING FILTER | May 1, 1990 | Substantially Equivalent |
| K896773 | DISPOSABLE FACE MASK | Jan 12, 1990 | Substantially Equivalent |
| K881812 | AERO-MIST NEBULIZER | Jul 18, 1988 | Substantially Equivalent |
| K873930 | AEROSOL DELIVERY SYSTEM (AERO-TECH II) | Dec 7, 1987 | Substantially Equivalent |
| K800023 | LUNG AEROSOL UNIT | Jan 1, 1985 | Substantially Equivalent |