The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for Dinamap Mps Portable Monitor.
Device ID | K971569 |
510k Number | K971569 |
Device Name: | DINAMAP MPS PORTABLE MONITOR |
Classification | System, Network And Communication, Physiological Monitors |
Applicant | JOHNSON & JOHNSON MEDICAL, INC. 4110 GEORGE RD. Tampa, FL 33634 |
Contact | Annette M Hillring |
Correspondent | Annette M Hillring JOHNSON & JOHNSON MEDICAL, INC. 4110 GEORGE RD. Tampa, FL 33634 |
Product Code | MSX |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-04-29 |
Decision Date | 1997-09-19 |
Summary: | summary |