The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Pb100 Diagnostic Spirometer.
| Device ID | K911143 |
| 510k Number | K911143 |
| Device Name: | PB100 DIAGNOSTIC SPIROMETER |
| Classification | Calculator, Pulmonary Function Interpretor (diagnostic) |
| Applicant | PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
| Contact | Timothy D Samsel |
| Correspondent | Timothy D Samsel PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
| Product Code | BZM |
| CFR Regulation Number | 868.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-14 |
| Decision Date | 1991-11-29 |