FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HME
K Number: K944194
·
Decision Sep 13, 1994
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
72
Applicant Total
3
Review Days
15
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Basic Information
- Device Name
- DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HME
- K Number
- K944194
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Med-Tek Innovations, Inc.
- Date Received
- August 29, 1994
- Decision Date
- September 13, 1994
- Product Code
- BYD
- 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 |
|---|---|---|---|
| BYD | Condenser, Heat And Moisture (Artificial Nose) | FDA class 1 | Anesthesiology |
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