The following data is part of a premarket notification filed by Perkinelmer, Inc with the FDA for Perkinelmer, Xrpad 4343 F Med Flat Panel Detector.
| Device ID | K142698 |
| 510k Number | K142698 |
| Device Name: | PerkinElmer, XRpad 4343 F MED Flat Panel Detector |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | PerkinElmer, Inc 940 Winter Street Waltham, MA 02451 |
| Contact | Dawn Spooner |
| Correspondent | Dawn Spooner PerkinElmer, Inc 940 Winter Street Waltham, MA 02451 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-22 |
| Decision Date | 2014-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812589020085 | K142698 | 000 |