Mamm-Aire CP
FDA 510(k) K893681 · Custom Medical Products, Ltd.
510(k) numberK893681
Submission
- Device name
- Mamm-Aire CP
- Applicant
- Custom Medical Products, Ltd.
Deer Park, NY, US - Received
- May 16, 1989
- Decision date
- July 20, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IZO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K954666 | MPH50, MPH65, and MPH80IZO · Traditional | GE Medical Systems | 11/24/1995SE |
| K953582 | HFX350, 30KW, 300MA, 1 or 3 Phase Radiographic & Fluoroscopic X-Ray GeneratorIZO · Traditional | Varian Canada, Inc. | 09/26/1995SE |
| K953831 | N 800 HFIZO · Traditional | Nucletron-Oldelft Corp. | 09/08/1995SE |
| K952822 | Shimadzu X-Ray High Viltage Generator AHD150GIZO · Traditional | Shimadzu Corp. | 07/12/1995SE |
| K952265 | Milestonw 350/450/550HF, PCX N350/450/550HF, Top-X 350/450/550HF Radiographic X-Ray…IZO · Traditional | Control-X, Inc. | 07/06/1995SE |
| K950883 | Polydoros SX 65 and 80IZO · Traditional | Siemens Medical Solutions USA, Inc. | 04/03/1995SE |
| K950694 | Compact-XIZO · Traditional | Electromed Intl., Ltd. | 03/31/1995SE |
| K950291 | Digital 625HFIZO · Traditional | Fischer Imaging Corp. | 03/23/1995SE |
| K950041 | Sii 360 AprIZO · Traditional | Scott Imaging Intl., Inc. | 03/21/1995SE |
| K950040 | Sii 525 AprIZO · Traditional | Scott Imaging Intl., Inc. | 03/21/1995SE |
More from Scott Imaging Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K994199 | Various Sterile and Non-Sterile Surgical Drapes, (I.E., Disposables Minor Procedure…KKX · Traditional | 06/09/2000SE |
| K931417 | Sterile Equipment CoversMMP · Traditional | 07/06/1995SE |
| K931456 | Surgical Drape and Gown TrayFYA · Traditional | 07/08/1994SE |
| K931455 | Head SheetKKX · Traditional | 05/05/1994SE |
| K931418 | Surgical DrapeKKX · Traditional | 05/05/1994SE |
| K930815 | Abdominal / Thoracic Patient DrapeKKX · Traditional | 05/05/1994SE |
| K931844 | Custom Procedure Medical Tray or KitLRO · Traditional | 01/25/1994SEKD |
| K926519 | Surgical GownFYA · Traditional | 08/12/1993SE |
| K900848 | Enema Kit 'Straight' DesignFCE · Traditional | 04/13/1990SE |
| K900847 | Enema Kit 'Y' DesignFCE · Traditional | 04/13/1990SE |
Questions and answers
When was Mamm-Aire CP cleared by the FDA?
Mamm-Aire CP (K893681) received a 510(k) decision of Substantially Equivalent on July 20, 1989, 65 days after the submission was received.
What is the product code of K893681?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.