The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Pb240 Patient Monitor/pulse Oximeter.
Device ID | K871864 |
510k Number | K871864 |
Device Name: | PB240 PATIENT MONITOR/PULSE OXIMETER |
Classification | Oximeter |
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 | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-13 |
Decision Date | 1987-06-24 |