The following data is part of a premarket notification filed by Isolation Systems, Inc. with the FDA for Failsafe - Portable Infection Control Systems.
| Device ID | K022260 |
| 510k Number | K022260 |
| Device Name: | FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS |
| Classification | Chamber, Patient Isolation |
| Applicant | ISOLATION SYSTEMS, INC. 79 FILLMORE AVE. Tonawanda, NY 14150 -2335 |
| Contact | Ted Ulatowski |
| Correspondent | Ted Ulatowski ISOLATION SYSTEMS, INC. 79 FILLMORE AVE. Tonawanda, NY 14150 -2335 |
| Product Code | LGM |
| CFR Regulation Number | 880.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-28 |
| Decision Date | 2002-08-29 |