The following data is part of a premarket notification filed by Peace Medical, Inc. with the FDA for Demistifier Isolation Chamber.
| Device ID | K902161 |
| 510k Number | K902161 |
| Device Name: | DEMISTIFIER ISOLATION CHAMBER |
| Classification | Apparatus, Gas-scavenging |
| Applicant | PEACE MEDICAL, INC. 50 S.CENTER ST. SUITE 11 Orange, NJ 07050 |
| Contact | Kevin Fegan |
| Correspondent | Kevin Fegan PEACE MEDICAL, INC. 50 S.CENTER ST. SUITE 11 Orange, NJ 07050 |
| Product Code | CBN |
| CFR Regulation Number | 868.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-15 |
| Decision Date | 1990-10-15 |