The following data is part of a premarket notification filed by Impact Instrumentation, Inc. with the FDA for Impact, Universal Single-limb, Ventilator Circuit, Model 820-0099-00.
| Device ID | K022062 |
| 510k Number | K022062 |
| Device Name: | IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 |
| Classification | Accessory To Continuous Ventilator (respirator) |
| Applicant | IMPACT INSTRUMENTATION, INC. 27 FAIRFIELD PL. P.O. BOX 508 West Caldwell, NJ 07006 -0508 |
| Contact | Leslie H Sherman |
| Correspondent | Leslie H Sherman IMPACT INSTRUMENTATION, INC. 27 FAIRFIELD PL. P.O. BOX 508 West Caldwell, NJ 07006 -0508 |
| Product Code | MOD |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-25 |
| Decision Date | 2003-05-06 |
| Summary: | summary |