The following data is part of a premarket notification filed by Novel Electronics, Inc. with the FDA for Micro-emed-system.
| Device ID | K902967 |
| 510k Number | K902967 |
| Device Name: | MICRO-EMED-SYSTEM |
| Classification | Transducer, Miniature Pressure |
| Applicant | NOVEL ELECTRONICS, INC. 511 ELEVENTH AVENUE SOUTH SUITE 266, BOX 82 Minneapolis, MN 55415 |
| Contact | Susan Diekrager |
| Correspondent | Susan Diekrager NOVEL ELECTRONICS, INC. 511 ELEVENTH AVENUE SOUTH SUITE 266, BOX 82 Minneapolis, MN 55415 |
| Product Code | IKE |
| CFR Regulation Number | 890.1615 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-06 |
| Decision Date | 1990-09-17 |