The following data is part of a premarket notification filed by Pollak (intl.), Ltd. with the FDA for Infussion Alarm System I.a.s. Cat.#1118.
| Device ID | K802011 |
| 510k Number | K802011 |
| Device Name: | INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 |
| Classification | Monitor, Electric For Gravity Flow Infusion Systems |
| Applicant | POLLAK (INTL.), LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FLN |
| CFR Regulation Number | 880.2420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-20 |
| Decision Date | 1980-10-31 |