The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for X-scribe Ii.
| Device ID | K022618 |
| 510k Number | K022618 |
| Device Name: | X-SCRIBE II |
| Classification | Electrocardiograph |
| Applicant | MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
| Contact | Harlan Van Matre |
| Correspondent | Harlan Van Matre MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-07 |
| Decision Date | 2002-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812345029987 | K022618 | 000 |
| 00817655022543 | K022618 | 000 |
| 00817655022536 | K022618 | 000 |
| 00817655022215 | K022618 | 000 |
| 00817655022154 | K022618 | 000 |
| 00817655021997 | K022618 | 000 |
| 00817655021980 | K022618 | 000 |
| 00817655021836 | K022618 | 000 |
| 00817655021287 | K022618 | 000 |
| 00817655020730 | K022618 | 000 |
| 00817655020723 | K022618 | 000 |
| 00817655020648 | K022618 | 000 |
| 00812345021790 | K022618 | 000 |
| 00812345024838 | K022618 | 000 |
| 00812345027556 | K022618 | 000 |
| 00812345027549 | K022618 | 000 |
| 00812345027532 | K022618 | 000 |
| 00812345027525 | K022618 | 000 |
| 00812345027518 | K022618 | 000 |
| 00812345027501 | K022618 | 000 |
| 00812345027495 | K022618 | 000 |
| 00812345027488 | K022618 | 000 |
| 00812345027471 | K022618 | 000 |
| 00812345024944 | K022618 | 000 |
| 00812345024845 | K022618 | 000 |
| 00817655020082 | K022618 | 000 |