FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
ICOR AGENT MONITOR
K Number: K883532
·
Decision Nov 4, 1988
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
21
Applicant Total
16
Review Days
78
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
- ICOR AGENT MONITOR
- K Number
- K883532
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1500
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Icor AB
- Date Received
- August 18, 1988
- Decision Date
- November 4, 1988
- Product Code
- CBQ
- 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 |
|---|---|---|---|
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CBQ), ordered by most recent decision date.
PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B
FDA 510(k)
FDA Class 2
·Anesthesiology
MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5
FDA 510(k)
FDA Class 2
·Anesthesiology
OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
OHMEDA MODEL 5330 ANESTHETIC MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
DATASCOPE MULTINEX II
FDA 510(k)
FDA Class 2
·Anesthesiology
AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Icor AB
| K Number | Device Name | ||
|---|---|---|---|
| K954402 | ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) | May 22, 1996 | Substantially Equivalent |
| K953507 | TYPE 1 & 2 (HUMIDAIR I & II) | Sep 7, 1995 | Substantially Equivalent |
| K952325 | ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) | Jul 31, 1995 | Substantially Equivalent |
| K952823 | FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE | Jul 13, 1995 | Substantially Equivalent |
| K941987 | HEAT AND MOISTURE EXCHANGERS AND FILTERS | Aug 15, 1994 | Substantially Equivalent |
| K940041 | COLIBRI | Jul 27, 1994 | Substantially Equivalent |
| K941436 | AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF | Jun 8, 1994 | Substantially Equivalent |
| K925622 | FHB, FHB-T, FHBFLEX, FHBFLEX-T | May 26, 1993 | Substantially Equivalent |
| K914416 | BREATH-EASY, MODIFICATION | Jun 23, 1992 | Substantially Equivalent |
| K904338 | ICOR HCH 4, ICOR HCH 7 | Dec 4, 1990 | Substantially Equivalent |