Fraser Harlake Dental Anti-Polution Sys
FDA 510(k) K833692 · Fraser Harlake, Inc.
510(k) numberK833692
Submission
- Device name
- Fraser Harlake Dental Anti-Polution Sys
- Applicant
- Fraser Harlake, Inc.
Mchenry, IL, US - Received
- October 18, 1983
- Decision date
- November 29, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CBN – Apparatus, Gas-Scavenging
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5430
- Specialty
- Anesthesiology
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More from Minrad, Inc.
| 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 |
| 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 |
Questions and answers
When was Fraser Harlake Dental Anti-Polution Sys cleared by the FDA?
Fraser Harlake Dental Anti-Polution Sys (K833692) received a 510(k) decision of Substantially Equivalent on November 29, 1983, 42 days after the submission was received.
What is the product code of K833692?
The FDA product code is CBN – Apparatus, Gas-Scavenging, a Class II (moderate risk) device regulated under 21 CFR 868.5430.