The following data is part of a premarket notification filed by At Medical Uab with the FDA for Xq-1 Incubator.
| Device ID | K133742 |
| 510k Number | K133742 |
| Device Name: | XQ-1 INCUBATOR |
| Classification | Accessory, Assisted Reproduction |
| Applicant | AT MEDICAL UAB DRAUGYSTES G.19 Kaunas, LT 51230 |
| Contact | Thomas Pedersen |
| Correspondent | Thomas Pedersen AT MEDICAL UAB DRAUGYSTES G.19 Kaunas, LT 51230 |
| Product Code | MQG |
| CFR Regulation Number | 884.6120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-09 |
| Decision Date | 2014-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04779041940106 | K133742 | 000 |