The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Portable Ventilator Patient Circuit.
Device ID | K873900 |
510k Number | K873900 |
Device Name: | PORTABLE VENTILATOR PATIENT CIRCUIT |
Classification | Set, Tubing And Support, Ventilator (w Harness) |
Applicant | PURITAN BENNETT CORP. 4865 STERLING DR. Boulder, CO 80301 |
Contact | Steven J Ojala |
Correspondent | Steven J Ojala PURITAN BENNETT CORP. 4865 STERLING DR. Boulder, CO 80301 |
Product Code | BZO |
CFR Regulation Number | 868.5975 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-24 |
Decision Date | 1987-10-30 |