Mamm-Aire
FDA 510(k) K863890 · Ar Custom Medical Products, Ltd.
510(k) numberK863890
Submission
- Device name
- Mamm-Aire
- Applicant
- Ar Custom Medical Products, Ltd.
Deer Park, NY, US - Received
- October 6, 1986
- Decision date
- October 14, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KXH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K122174 | Pediatric Positioner Pad SetKXH · Traditional | Ge Healthcare Coils (Usa Instruments, Inc.) | 11/16/2012SE |
| K953246 | OctorollKXH · Traditional | Octostop, Inc. | 09/29/1995SE |
| K930124 | Variant of Octostop and OctopaqueKXH · Traditional | Octostop, Inc. | 02/09/1994SE |
| K933134 | Spectrum DG-P7000 Pediatric CradleKXH · Traditional | Spectrum X-Ray Corp. | 10/07/1993SE |
| K930357 | Accessory to Universal OctopaqueKXH · Traditional | Octostop, Inc. | 07/13/1993SE |
| K884292 | Stretcher TableKXH · Traditional | Fischer Imaging Corp. | 03/31/1989SE |
| K840463 | Digital CradleKXH · Traditional | Spectrum X-Ray Corp. | 02/21/1984SE |
| K813561 | Spectrum Pediatric Cardle TableKXH · Traditional | Spectrum X-Ray Corp. | 01/29/1982SE |
Questions and answers
When was Mamm-Aire cleared by the FDA?
Mamm-Aire (K863890) received a 510(k) decision of Substantially Equivalent on October 14, 1986, 8 days after the submission was received.
What is the product code of K863890?
The FDA product code is KXH – Cradle, Patient, Radiologic, a Class I (low risk) device regulated under 21 CFR 892.1830.