The following data is part of a premarket notification filed by Medimicro Systems, Inc. with the FDA for Burrows-knudson Automated Lung Function Inter. Sys.
| Device ID | K880550 |
| 510k Number | K880550 |
| Device Name: | BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS |
| Classification | Calculator, Pulmonary Function Interpretor (diagnostic) |
| Applicant | MEDIMICRO SYSTEMS, INC. 3107 N. JACKSON AVE. Tucson, AZ 85719 |
| Contact | Ronald C Slatin |
| Correspondent | Ronald C Slatin MEDIMICRO SYSTEMS, INC. 3107 N. JACKSON AVE. Tucson, AZ 85719 |
| Product Code | BZM |
| CFR Regulation Number | 868.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-09 |
| Decision Date | 1988-07-25 |