FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
PRIMA OXYGEN MONITOR
K Number: K010318
·
Decision Jul 23, 2001
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
120
Applicant Total
9
Review Days
171
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
- PRIMA OXYGEN MONITOR
- K Number
- K010318
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1720
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Penlon , Ltd.
- Date Received
- February 2, 2001
- Decision Date
- July 23, 2001
- Product Code
- CCL
- 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 |
|---|---|---|---|
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CCL), ordered by most recent decision date.
OxyMinder Pro (10310)
FDA 510(k)
FDA Class 2
·Anesthesiology
Smart Check O2 (MA0236)
FDA 510(k)
FDA Class 2
·Anesthesiology
Maxtec MaxO2 ME+p
FDA 510(k)
FDA Class 2
·Anesthesiology
Percent Oxygen Sensors
FDA 510(k)
FDA Class 2
·Anesthesiology
OxyMinder
FDA 510(k)
FDA Class 2
·Anesthesiology
Accu O2 Oxygen Analyzer
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Penlon , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K061102 | PRIMA ANAESTHESIA MACHINE | Jul 28, 2006 | Substantially Equivalent |
| K041076 | DELTA T | Aug 9, 2004 | Substantially Equivalent |
| K010317 | AV 800 VENTILATOR | Jul 23, 2001 | Substantially Equivalent |
| K002343 | SIGMA DELTA | Jun 8, 2001 | Substantially Equivalent |
| K961468 | QUIK-FIL VAPORIZER KEYED FILLER | Jul 16, 1996 | Substantially Equivalent |
| K960944 | PPV VAPORIZER (MODIFICATION) | Apr 2, 1996 | Substantially Equivalent |
| K953179 | CLM LARYNGOSCOPE | Oct 6, 1995 | Substantially Equivalent |
| K942545 | SIGMA ELITE | Feb 3, 1995 | Substantially Equivalent |