The following data is part of a premarket notification filed by Andreas Fahl Medizintechnik-vertrieb Gmbh with the FDA for Fahl Tracheostomy Tubes (multiple).
| Device ID | K123699 |
| 510k Number | K123699 |
| Device Name: | FAHL TRACHEOSTOMY TUBES (MULTIPLE) |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | ANDREAS FAHL MEDIZINTECHNIK-VERTRIEB GMBH AUGUST-HORCH-STR. 4A Koeln, DE 51149 |
| Contact | Claudia Winterschladen |
| Correspondent | Claudia Winterschladen ANDREAS FAHL MEDIZINTECHNIK-VERTRIEB GMBH AUGUST-HORCH-STR. 4A Koeln, DE 51149 |
| Product Code | JOH |
| Subsequent Product Code | BTO |
| Subsequent Product Code | BTR |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-03 |
| Decision Date | 2013-08-12 |
| Summary: | summary |