The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed Pm200 Inflation Manometer.
| Device ID | K843448 |
| 510k Number | K843448 |
| Device Name: | SCIMED PM200 INFLATION MANOMETER |
| Classification | Syringe, Balloon Inflation |
| Applicant | SCIMED LIFE SYSTEMS, INC. 13000 COUNTY RD 6 Minneapolis, MN 55441 |
| Contact | Darlene A Thometzq |
| Correspondent | Darlene A Thometzq SCIMED LIFE SYSTEMS, INC. 13000 COUNTY RD 6 Minneapolis, MN 55441 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-05 |
| Decision Date | 1984-10-23 |