510(k) K022062
- Device
- IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00
- Applicant
- IMPACT INSTRUMENTATION, INC.
- 510(k) number
- K022062
- Product code
- MOD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-05-06
- Date received
- 2002-06-25
- Regulation
- 868.5895
- Classification name
- Accessory To Continuous Ventilator (respirator)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LESLIE H SHERMAN
- Address
- 27 Fairfield Pl. P.O. Box 508 West Caldwell NJ US 07006 07006
FDA Registration Numbers#
- 9617566
- 2024500
- 9710644
- 3004428458
- 3010817335
- 2028807
- 3033571078
- 3005855942
Source Documents#
Other 510(k) Records For Product Code MOD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260051 | CorVision® (91-205-Z0014) | CorVent® Medical, Inc. | 2026-05-12 |
| K242485 | EveryWare | Breas Medical AB | 2025-05-20 |
| K161411 | Care Cycle Connect Application | Respironics, Inc. | 2017-02-17 |
| K091461 | BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE | Cardiopulmonary Corp. | 2009-08-14 |
| K052751 | VENTLINK SYSTEM | Mediserve Information Systems, Inc. | 2005-12-23 |
| K052244 | IISIS, VERSION 1.0 | Innovision Medical Technologies, LLC | 2005-10-13 |
| K040712 | AIR SAFETY HEPA, MODEL 3500 | Air Safety, Ltd. | 2004-06-03 |
| K010401 | TRI-PLEX ADAPTER | The Medical Device Group, Inc. | 2002-10-30 |
| K011861 | BERNOULLI VENTILATOR MANAGEMENT SYSTEM | Cardiopulmonary Corp. | 2001-11-06 |
| K963633 | VENTNET; CENTRAL MONITORING STATION | Puritan Bennett Corp. | 1996-12-16 |
| K935788 | BICORE SMARTCATH INTRATRACHEAL CATHETER | Bicore Monitoring Systems | 1995-07-03 |
| K936156 | VENTILATION MECHANICS MONITOR MODEL VMM-100 | Smith Industries Medical Systems (Sims) | 1995-06-27 |
| K940739 | NEWPORT COMMUNICAT PROTOCOL INTERFACE ADAPTOR | Newport Medical Instruments, Inc. | 1995-03-07 |
Legacy Summary#
summary
FDA Review#
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