The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for Dinamap Select Multi-parameter System.
| Device ID | K955113 |
| 510k Number | K955113 |
| Device Name: | DINAMAP SELECT MULTI-PARAMETER SYSTEM |
| Classification | Electrocardiograph |
| Applicant | JOHNSON & JOHNSON MEDICAL, INC. 4110 GEORGE RD. Tampa, FL 33634 |
| Contact | Annette M Hilring |
| Correspondent | Annette M Hilring JOHNSON & JOHNSON MEDICAL, INC. 4110 GEORGE RD. Tampa, FL 33634 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-08 |
| Decision Date | 1996-08-15 |
| Summary: | summary |