FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEMAND OXYGEN SAVER SYSTEM (D02S)
K Number: K861423
·
Decision May 16, 1986
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
171
Applicant Total
3
Review Days
30
Basic Information
- Device Name
- DEMAND OXYGEN SAVER SYSTEM (D02S)
- K Number
- K861423
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- APPLIED MEMBRANE TECHNOLOGY, INC.
- Date Received
- April 16, 1986
- Decision Date
- May 16, 1986
- 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.
RTM Sense (A-0001)
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
Makani Science Respiration Monitoring System
FDA 510(k)
FDA Class 2
·Anesthesiology
Airmod
FDA 510(k)
FDA Class 2
·Anesthesiology
Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
FDA 510(k)
FDA Class 2
·Anesthesiology