Company ยท US
Fraser Harlake, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 1984. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CBN | Apparatus, Gas-Scavenging | 2 |
| BSZ | Gas-Machine, Anesthesia | 1 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 |
| CAD | Vaporizer, Anesthesia, Non-Heated | 1 |
| CBK | Ventilator, Continuous, Facility Use | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 14, 1984 | K841903 | FRASER HARLAKE EMERG. CARE SUCTION SYS Fraser Harlake, Inc. | BTA |
| May 14, 1984 | K833799 | SPHYGOMANO METER Fraser Harlake, Inc. | DXN |
| Apr 24, 1984 | K841496 | FRASER HARLAKE HOPE III RESUSCITATOR Fraser Harlake, Inc. | BTM |
| Nov 29, 1983 | K833692 | FRASER HARLAKE DENTAL ANTI-POLUTION SYS Fraser Harlake, Inc. | CBN |
| Nov 14, 1983 | K833151 | BOYLE SYSTEM ANESTHESIA GAS MACHINE Fraser Harlake, Inc. | BSZ |
| Jul 7, 1983 | K831427 | CYPRANE TEC 4 CONTINUOUS FLOW VAPOR. Fraser Harlake, Inc. | CAD |
| Aug 19, 1982 | K822040 | POWERED EMERGENCY VENTILATOR Fraser Harlake, Inc. | CBK |
| Jun 25, 1982 | K821744 | FRASER HARLAKE NITRONOX SCAVENGER Fraser Harlake, Inc. | CBN |
| Jan 15, 1981 | K802943 | POSITIVE END EXPIRATORY PRESSURE VALVE Fraser Harlake, Inc. | BYE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||