The following data is part of a premarket notification filed by Medical Measurements, Inc. with the FDA for Modified Ict/b Intracranial Press. Trans. Epidural.
Device ID | K863479 |
510k Number | K863479 |
Device Name: | MODIFIED ICT/B INTRACRANIAL PRESS. TRANS. EPIDURAL |
Classification | Device, Monitoring, Intracranial Pressure |
Applicant | MEDICAL MEASUREMENTS, INC. 53 MAIN ST. Hackensack, NJ 07601 |
Contact | William Sones |
Correspondent | William Sones MEDICAL MEASUREMENTS, INC. 53 MAIN ST. Hackensack, NJ 07601 |
Product Code | GWM |
CFR Regulation Number | 882.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-09 |
Decision Date | 1986-10-14 |