Icor AB
Bromma, SE
Icor AB appears in FDA device records in Bromma, SE. FDA records list 16 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 16
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 16 510(k) clearances for Icor AB between 1986 and 1996. The busiest year on record is 1990, with 3. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 1 |
| 1987 | 1 |
| 1988 | 2 |
| 1990 | 3 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 3 |
| 1995 | 3 |
| 1996 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K954402 | ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) | CCK | Substantially Equivalent | |
| K953507 | TYPE 1 & 2 (HUMIDAIR I & II) | BYD | Substantially Equivalent | |
| K952325 | ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) | CCK | Substantially Equivalent | |
| K952823 | FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE | BYD | Substantially Equivalent | |
| K941987 | HEAT AND MOISTURE EXCHANGERS AND FILTERS | BYD | Substantially Equivalent | |
| K940041 | COLIBRI | BTR | Substantially Equivalent | |
| K941436 | AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF | BYD | Substantially Equivalent | |
| K925622 | FHB, FHB-T, FHBFLEX, FHBFLEX-T | BYD | Substantially Equivalent | |
| K914416 | BREATH-EASY, MODIFICATION | HME | Substantially Equivalent | |
| K904338 | ICOR HCH 4, ICOR HCH 7 | BYD | Substantially Equivalent | |
| K900150 | HCH 9165, 9165 S, 9166, HFH, HFH-T HEAT MOISTURE | BYD | Substantially Equivalent | |
| K895935 | ICOR CMU Q PLUS | BZL | Substantially Equivalent | |
| K883532 | ICOR AGENT MONITOR | CBQ | Substantially Equivalent | |
| K881308 | BREATH-EASY | BYD | Substantially Equivalent | |
| K872371 | ICOR NEONATAL HCH | BYD | Substantially Equivalent | |
| K854927 | ICOR CALARIC MEASUREMENT UNIT (CMU) | BZL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain