The following data is part of a premarket notification filed by Medical Graphics Corp. with the FDA for Medical Graphics Desktop Diagnostic System.
| Device ID | K871711 |
| 510k Number | K871711 |
| Device Name: | MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEM |
| Classification | Calculator, Pulmonary Function Interpretor (diagnostic) |
| Applicant | MEDICAL GRAPHICS CORP. 350 OAK GROVE PKWY. St. Paul, MN 55127 -8599 |
| Contact | Ronald H Bergeson |
| Correspondent | Ronald H Bergeson MEDICAL GRAPHICS CORP. 350 OAK GROVE PKWY. St. Paul, MN 55127 -8599 |
| Product Code | BZM |
| CFR Regulation Number | 868.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-01 |
| Decision Date | 1987-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B3687620429050 | K871711 | 000 |
| B3687620429040 | K871711 | 000 |
| B3687620420030 | K871711 | 000 |
| 00810016250364 | K871711 | 000 |
| 00810016250357 | K871711 | 000 |
| 00810016250371 | K871711 | 000 |