The following data is part of a premarket notification filed by Impact Instrumentation, Inc. with the FDA for Impact Model 308.
| Device ID | K841538 |
| 510k Number | K841538 |
| Device Name: | IMPACT MODEL 308 |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | IMPACT INSTRUMENTATION, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-16 |
| Decision Date | 1984-06-11 |