Resubmitted Radioaerosol Cont. System MP-963
FDA 510(k) K893532 · Medipart Jerry Alexander
510(k) numberK893532
Submission
- Device name
- Resubmitted Radioaerosol Cont. System MP-963
- Applicant
- Medipart Jerry Alexander
Cary, IL, US - Received
- May 8, 1989
- Decision date
- August 21, 1989
- 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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|---|---|---|---|
| K223452 | Nitronox Scavenger PlusCBN · Traditional | Parker Hannifin Corporation | 03/05/2023SE |
| K193646 | Dynamic Gas Scavenging System 2 (DGSS - 2)CBN · Special | Anesthetic Gas Reclamation, Inc. | 12/04/2020SE |
| K160950 | MiniscavCBN · Traditional | Sedation Systems, LLC | 05/05/2017SE |
| K142138 | Iso-Gard MaskCBN · Traditional | Teleflexmedical, Inc. | 10/30/2014SE |
| K132729 | Iso-Gard MaskCBN · Special | Teleflexmedical, Inc. | 01/09/2014SE |
| K123176 | Iso-Gard Clearair MaskCBN · Traditional | Teleflexmedical, Inc. | 02/14/2013SE |
| K110930 | Active Waste Gas ScavengerCBN · Special | G. Dundas Co.,Inc. | 06/23/2011SE |
| K092031 | Vapor-Clear, Model 100CBN · Traditional | Axon Medical, Inc. | 04/16/2010SE |
| K080039 | Passive Waste Gas Scavenger, Model 14600CBN · Traditional | G. Dundas Co.,Inc. | 04/14/2008SE |
| K072255 | Minrad Inc. Nasal Scavenging CircuitCBN · Traditional | Minrad, Inc. | 10/18/2007SE |
More from Minrad, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K896885 | Disposable Respirtory Kit (MP-200)IYT · Traditional | 02/26/1990SE |
| K896125 | Medipart Disposable XENON-133 Rebreathing MP-0133MIYT · Traditional | 02/01/1990SE |
| K896476 | Disp. Radioaerosol Kit (MP-400-M) to Fit ShieldIYT · Traditional | 01/22/1990SE |
| K896475 | Disp. Radioaerosol Kit (MP-400) to Fit Lead ShieldIYT · Traditional | 01/22/1990SE |
| K896124 | Medipart Disposable XENON-133 Rebreathing MP-0133IYT · Traditional | 01/22/1990SE |
| K894138 | Medipart Disposable Aerosol System MP-070-PTDCAF · Traditional | 09/26/1989SE |
| K862795 | MP-070-M Radioaerosol KitIYT · Traditional | 08/01/1986SE |
| K862794 | MP-070 Radioaerosol KitIYT · Traditional | 08/01/1986SE |
| K862793 | MP-066-M Radioaerosol KitIYT · Traditional | 08/01/1986SE |
| K862792 | MP-066 Radioaerosol KitIYT · Traditional | 08/01/1986SE |
Questions and answers
When was Resubmitted Radioaerosol Cont. System MP-963 cleared by the FDA?
Resubmitted Radioaerosol Cont. System MP-963 (K893532) received a 510(k) decision of Substantially Equivalent on August 21, 1989, 105 days after the submission was received.
What is the product code of K893532?
The FDA product code is CBN – Apparatus, Gas-Scavenging, a Class II (moderate risk) device regulated under 21 CFR 868.5430.