The following data is part of a premarket notification filed by Medical Graphics Corp. with the FDA for 1085 Ultimate E Plethysmograph.
| Device ID | K943259 |
| 510k Number | K943259 |
| Device Name: | 1085 ULTIMATE E PLETHYSMOGRAPH |
| Classification | Flowmeter, Nonback-pressure Compensated, Bourdon Gauge |
| Applicant | MEDICAL GRAPHICS CORP. 350 OAK GROVE PKWY. St. Paul, MN 55127 -8599 |
| Contact | Kathryn A Neumann |
| Correspondent | Kathryn A Neumann MEDICAL GRAPHICS CORP. 350 OAK GROVE PKWY. St. Paul, MN 55127 -8599 |
| Product Code | CCN |
| CFR Regulation Number | 868.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-06 |
| Decision Date | 1995-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B368830008902 | K943259 | 000 |
| B368830007902 | K943259 | 000 |
| B368830005002 | K943259 | 000 |
| 00810016250241 | K943259 | 000 |