Fraser Harlake, Inc.
Medical device manufacturer in Walker, MI.
9510(k) clearances
0PMA approvals
0recalls
Device types
- CBN Apparatus, Gas-Scavenging 2
- BYE Attachment, Breathing, Positive End… 1
- CBK Ventilator, Continuous, Facility Use 1
- CAD Vaporizer, Anesthesia, Non-Heated 1
- BSZ Gas-Machine, Anesthesia 1
- BTM Ventilator, Emergency, Manual (Resuscitator) 1
- DXN System, Measurement, Blood-Pressure… 1
- BTA Pump, Portable, Aspiration (Manual Or… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K841903 | Fraser Harlake Emerg. Care Suction SysBTA · Traditional | 06/14/1984SE |
| K833799 | Sphygomano MeterDXN · Traditional | 05/14/1984SE |
| K841496 | Fraser Harlake Hope III ResuscitatorBTM · Traditional | 04/24/1984SE |
| K833692 | Fraser Harlake Dental Anti-Polution SysCBN · Traditional | 11/29/1983SE |
| K833151 | Boyle System Anesthesia Gas MachineBSZ · Traditional | 11/14/1983SE |
| K831427 | Cyprane Tec 4 Continuous Flow Vapor.CAD · Traditional | 07/07/1983SE |
| K822040 | Powered Emergency VentilatorCBK · Traditional | 08/19/1982SE |
| K821744 | Fraser Harlake Nitronox ScavengerCBN · Traditional | 06/25/1982SE |
| K802943 | Positive End Expiratory Pressure ValveBYE · Traditional | 01/15/1981SE |