FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR
K Number: K040069
·
Decision May 5, 2004
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
160
Applicant Total
4
Review Days
112
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Basic Information
- Device Name
- DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR
- K Number
- K040069
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dymedix, Inc.
- Date Received
- January 14, 2004
- Decision Date
- May 5, 2004
- Product Code
- MNR
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MNR | Ventilatory Effort Recorder | FDA class 2 | Anesthesiology |
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Other Clearances by Dymedix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K040605 | DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100 | Apr 26, 2004 | Substantially Equivalent |
| K020468 | CHIN ELECTRODE | Apr 16, 2002 | Substantially Equivalent |
| K001030 | RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S | May 11, 2000 | Substantially Equivalent |