FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM
K Number: K003472
·
Decision Jun 4, 2001
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
286
Applicant Total
4
Review Days
208
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
- INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM
- K Number
- K003472
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5440
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sequal Technologies, Inc.
- Date Received
- November 8, 2000
- Decision Date
- June 4, 2001
- Product Code
- CAW
- 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 |
|---|---|---|---|
| CAW | Generator, Oxygen, Portable | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAW), ordered by most recent decision date.
Portable Oxygen Concentrator
FDA 510(k)
FDA Class 2
·Anesthesiology
Oxygen Concentrator (OX-5A, OX-5C)
FDA 510(k)
FDA Class 2
·Anesthesiology
OxyGo Portable Oxygen Concentrator (1400-7000)
FDA 510(k)
FDA Class 2
·Anesthesiology
DeVilbiss 5 Liter Oxygen Concentrator (555)
FDA 510(k)
FDA Class 2
·Anesthesiology
Oxygen Concentrator (J10A)
FDA 510(k)
FDA Class 2
·Anesthesiology
Oxygen Concentrator-P2-O5E
FDA 510(k)
FDA Class 2
·Anesthesiology