The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Burdick Division (e-500).
| Device ID | K861850 |
| 510k Number | K861850 |
| Device Name: | BURDICK DIVISION (E-500) |
| Classification | Electrocardiograph |
| Applicant | MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
| Contact | Timothy C Mickelson |
| Correspondent | Timothy C Mickelson MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-14 |
| Decision Date | 1986-08-28 |