The following data is part of a premarket notification filed by Medical Graphics Corp. with the FDA for Medgraphics Ultima System.
| Device ID | K061731 |
| 510k Number | K061731 |
| Device Name: | MEDGRAPHICS ULTIMA SYSTEM |
| Classification | Computer, Oxygen-uptake |
| Applicant | MEDICAL GRAPHICS CORP. 350 OAK GROVE PKWY. St. Paul, MN 55127 -8599 |
| Contact | Lynn Brosious |
| Correspondent | Lynn Brosious MEDICAL GRAPHICS CORP. 350 OAK GROVE PKWY. St. Paul, MN 55127 -8599 |
| Product Code | BZL |
| CFR Regulation Number | 868.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-20 |
| Decision Date | 2006-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B3688008600310 | K061731 | 000 |
| 00810016250142 | K061731 | 000 |
| 00810016250166 | K061731 | 000 |
| 00810016250173 | K061731 | 000 |
| 00810016250180 | K061731 | 000 |
| 00810016250197 | K061731 | 000 |
| 00810016250203 | K061731 | 000 |
| 00810016250210 | K061731 | 000 |
| 00810016250227 | K061731 | 000 |
| 00810016250135 | K061731 | 000 |
| 00810016250128 | K061731 | 000 |
| 00810016250036 | K061731 | 000 |
| 00810016250043 | K061731 | 000 |
| 00810016250050 | K061731 | 000 |
| 00810016250067 | K061731 | 000 |
| 00810016250074 | K061731 | 000 |
| 00810016250098 | K061731 | 000 |
| 00810016250104 | K061731 | 000 |
| 00810016250111 | K061731 | 000 |
| B368800810001 | K061731 | 000 |
| B368800810011 | K061731 | 000 |
| B368800840001 | K061731 | 000 |
| B368800840011 | K061731 | 000 |
| B3688008400210 | K061731 | 000 |
| B3688008400310 | K061731 | 000 |
| B368800850001 | K061731 | 000 |
| B368800860001 | K061731 | 000 |
| B368800860011 | K061731 | 000 |
| B3688008600210 | K061731 | 000 |
| B3688008300310 | K061731 | 000 |
| B3688008300210 | K061731 | 000 |
| B3688008100210 | K061731 | 000 |
| B3688008100310 | K061731 | 000 |
| B368800820001 | K061731 | 000 |
| B368800820011 | K061731 | 000 |
| B3688008200210 | K061731 | 000 |
| B3688008200310 | K061731 | 000 |
| B368800830001 | K061731 | 000 |
| B368800830011 | K061731 | 000 |
| 00810016250029 | K061731 | 000 |