The following data is part of a premarket notification filed by Medizin Systeme Boblingen Gmbh with the FDA for Pagewriter Tc35 Cardiograph.
| Device ID | K221141 |
| 510k Number | K221141 |
| Device Name: | PageWriter TC35 Cardiograph |
| Classification | Electrocardiograph |
| Applicant | Medizin Systeme Boblingen GmbH Hewlett-Packard Strasse 2 Boblingen, DE 71032 |
| Contact | Judy Yang |
| Correspondent | Judy Yang Medizin Systeme Boblingen GmbH Hewlett-Packard Strasse 2 Boblingen, DE 71032 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-19 |
| Decision Date | 2022-12-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838094819 | K221141 | 000 |
| 00884838048102 | K221141 | 000 |
| 00884838048089 | K221141 | 000 |