The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Modified Neuromuscular Transmission Monitor.
Device ID | K862149 |
510k Number | K862149 |
Device Name: | MODIFIED NEUROMUSCULAR TRANSMISSION MONITOR |
Classification | Stimulator, Nerve, Battery-powered |
Applicant | PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
Contact | Hartley C Ericson |
Correspondent | Hartley C Ericson PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
Product Code | BXN |
CFR Regulation Number | 868.2775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-06-04 |
Decision Date | 1986-06-19 |