The following data is part of a premarket notification filed by Pharma Systems, Inc. with the FDA for Extended Life Circuits.
| Device ID | K903055 |
| 510k Number | K903055 |
| Device Name: | EXTENDED LIFE CIRCUITS |
| Classification | Set, Tubing And Support, Ventilator (w Harness) |
| Applicant | PHARMA SYSTEMS, INC. 32 OAK PLACE Bernardsville, NJ 07924 |
| Contact | Hal Norris |
| Correspondent | Hal Norris PHARMA SYSTEMS, INC. 32 OAK PLACE Bernardsville, NJ 07924 |
| Product Code | BZO |
| CFR Regulation Number | 868.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-11 |
| Decision Date | 1990-11-09 |