Spectrum DG-P7000 Pediatric Cradle
FDA 510(k) K933134 · Spectrum X-Ray Corp.
510(k) numberK933134
Submission
- Device name
- Spectrum DG-P7000 Pediatric Cradle
- Applicant
- Spectrum X-Ray Corp.
Westville, NJ, US - Received
- June 28, 1993
- Decision date
- October 7, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| K930357 | Accessory to Universal OctopaqueKXH · Traditional | Octostop, Inc. | 07/13/1993SE |
| K884292 | Stretcher TableKXH · Traditional | Fischer Imaging Corp. | 03/31/1989SE |
| K863890 | Mamm-AireKXH · Traditional | Ar Custom Medical Products, Ltd. | 10/14/1986SE |
| K840463 | Digital CradleKXH · Traditional | Spectrum X-Ray Corp. | 02/21/1984SE |
| K813561 | Spectrum Pediatric Cardle TableKXH · Traditional | Spectrum X-Ray Corp. | 01/29/1982SE |
More from Spectrum X-Ray Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K931563 | Spectrum Mark I Special Procedures TableIXR · Traditional | 08/23/1993SE |
| K870707 | Pentamax 1 Model B Table SystemIXR · Traditional | 05/14/1987SE |
| K840463 | Digital CradleKXH · Traditional | 02/21/1984SE |
| K834494 | Spectrum X-Ray CorpIZZ · Traditional | 02/21/1984SE |
| K827450 | Simplamatic III · Traditional | 05/19/1982SE |
| K813561 | Spectrum Pediatric Cardle TableKXH · Traditional | 01/29/1982SE |
| K791812 | Spectrum Emergency & Trauma Table SystemIXR · Traditional | 11/05/1979SE |
| K791811 | Spectrum Automatic Chest Unit Model CKPX · Traditional | 10/26/1979SE |
Questions and answers
When was Spectrum DG-P7000 Pediatric Cradle cleared by the FDA?
Spectrum DG-P7000 Pediatric Cradle (K933134) received a 510(k) decision of Substantially Equivalent on October 7, 1993, 101 days after the submission was received.
What is the product code of K933134?
The FDA product code is KXH – Cradle, Patient, Radiologic, a Class I (low risk) device regulated under 21 CFR 892.1830.