The following data is part of a premarket notification filed by C.r. Bard Inc., Bard Electrophysiology Division with the FDA for Labsystem Pro Ep Recording System V3.1 Software.
| Device ID | K101331 |
| 510k Number | K101331 |
| Device Name: | LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION 55 TECHNOLOGY DR. Lowell, MA 01851 |
| Contact | Anastasia C Randall |
| Correspondent | Anastasia C Randall C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION 55 TECHNOLOGY DR. Lowell, MA 01851 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-11 |
| Decision Date | 2010-10-08 |
| Summary: | summary |