The following data is part of a premarket notification filed by Izi Medical Products Llc with the FDA for Disposable Passive Accessory For Medtronic Stealthstation System.
| Device ID | K142344 |
| 510k Number | K142344 |
| Device Name: | DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | IZI MEDICAL PRODUCTS LLC 5 Easter Ct Ste J Owings Mills, MD 21117 |
| Contact | Qiang Cao |
| Correspondent | Qiang Cao IZI MEDICAL PRODUCTS LLC 5 Easter Ct Ste J Owings Mills, MD 21117 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-22 |
| Decision Date | 2015-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815212022982 | K142344 | 000 |
| 00815212024320 | K142344 | 000 |
| 00815212022920 | K142344 | 000 |
| 00815212026690 | K142344 | 000 |
| 00815212026683 | K142344 | 000 |
| 20815212026816 | K142344 | 000 |
| 10815212026819 | K142344 | 000 |
| 00815212026850 | K142344 | 000 |
| 00815212026829 | K142344 | 000 |
| 00815212020360 | K142344 | 000 |
| 00815212020377 | K142344 | 000 |
| 00815212022944 | K142344 | 000 |
| 00815212022913 | K142344 | 000 |
| 00815212022180 | K142344 | 000 |
| 00815212022173 | K142344 | 000 |
| 00815212022166 | K142344 | 000 |
| 00815212022159 | K142344 | 000 |
| 00815212020391 | K142344 | 000 |
| 00815212020384 | K142344 | 000 |
| 00815212026812 | K142344 | 000 |