FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONSERVER
K Number: K024023
·
Decision Oct 1, 2003
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
70
Applicant Total
1
Review Days
300
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
- ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONSERVER
- K Number
- K024023
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Essex Medical Systems Plus
- Date Received
- December 5, 2002
- Decision Date
- October 1, 2003
- Product Code
- NFB
- 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 |
|---|---|---|---|
| NFB | Conserver, Oxygen | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NFB), ordered by most recent decision date.
Respond OC Conserving Regulator (130-0800)
FDA 510(k)
FDA Class 2
·Anesthesiology
Proxima
FDA 510(k)
FDA Class 2
·Anesthesiology
Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile
FDA 510(k)
FDA Class 2
·Anesthesiology
Apogee
FDA 510(k)
FDA Class 2
·Anesthesiology
Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
FDA 510(k)
FDA Class 2
·Anesthesiology
THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN
FDA 510(k)
FDA Class 2
·Anesthesiology