FDA 510(k)
FDA class 2
Substantially Equivalent - Subject to Tracking Reg.
🇺🇸 United States
SNORING SENSOR
K Number: K941759
·
Decision Nov 10, 1994
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
174
Applicant Total
1
Review Days
245
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SNORING SENSOR
- K Number
- K941759
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Applicant
- Epm Development Systems Corp.
- Date Received
- March 10, 1994
- Decision Date
- November 10, 1994
- Product Code
- BZQ
- 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 |
|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZQ), ordered by most recent decision date.
Respiration Rate algorithm
FDA 510(k)
FDA Class 2
·Anesthesiology
Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
FDA 510(k)
FDA Class 2
·Anesthesiology
Respiree Cardio- Respiratory Monitor System
FDA 510(k)
FDA Class 2
·Anesthesiology
RTMsense Respiratory Monitoring System
FDA 510(k)
FDA Class 2
·Anesthesiology
FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)
FDA 510(k)
FDA Class 2
·Anesthesiology
Philips VSC-MEDlib
FDA 510(k)
FDA Class 2
·Anesthesiology