Emerson In-Exsufflator, Models 2-CM & 2-CA
FDA 510(k) K924174 · J. H. Emerson Co.
510(k) numberK924174
Submission
- Device name
- Emerson In-Exsufflator, Models 2-CM & 2-CA
- Applicant
- J. H. Emerson Co.
Cambridge, MA, US - Received
- August 19, 1992
- Decision date
- November 17, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NHJ – Device, Positive Pressure Breathing, Intermittent
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5905
- Specialty
- Anesthesiology
Other 510(k)s with product code NHJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260604 | BiWaze Clear SystemNHJ · Traditional | Abmrc, LLC | 08/24/2026SE |
| K253001 | KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)NHJ · Traditional | Hunan Ruijiong Biotech Co., Ltd. | 06/16/2026SE |
| K242438 | ClearoNHJ · Traditional | Breas Medical AB | 05/16/2025SE |
| K231728 | BiWaze Clear SystemNHJ · Traditional | Abmrc, LLC | 04/08/2024SE |
| K213564 | BiWaze Clear SystemNHJ · Traditional | Abmrc, LLC | 12/21/2022SE |
| K200988 | Maximus SystemNHJ · Special | Hill-Rom Services Pte, Ltd. | 05/26/2020SE |
| K191912 | BiWaze CoughNHJ · Traditional | Abmrc, LLC | 03/27/2020SE |
| K192143 | Maximus SystemNHJ · Traditional | Hill-Rom Services Pte, Ltd. | 02/14/2020SE |
| K151689 | MetaNeb 4 SystemNHJ · Traditional | Hill-Rom Services Pte, Ltd. | 03/17/2016SE |
| K140598 | Pegaso Cough, Pegaso A-Cough, Pegaso A-Cough PercNHJ · Traditional | Dima Italia Srl | 10/16/2014SE |
More from Dima Italia Srl
| 510(k) | Device | Decision |
|---|---|---|
| K002598 | Emerson Cough Assist Model CA-3000 W/Automatic Timing and Model CM-3000 W/Manual TimingNHJ · Special | 11/22/2000SE |
| K920910 | Oxygen Powered Resuscitator for CPRBTL · Traditional | 01/12/1993SE |
| K902764 | Emerson 33-AN Negative Pressure Respirator AlarmBYT · Traditional | 11/19/1990SE |
| K896721 | Model 7-AT Treatment ChamberLGM · Traditional | 01/22/1990SE |
| K881808 | Emerson Chest Respirator, Model 33-CREBYT · Traditional | 08/04/1988SE |
| K873489 | Emerson Dispos Thoracic Drainage Set - 551-8000GCX · Traditional | 12/29/1987SE |
| K872937 | 97-TD Emerson Timer/Dimmer ControlIQA · Traditional | 09/24/1987SE |
| K872936 | 97-D Emerson Dimmer ControlIQA · Traditional | 09/24/1987SE |
| K864379 | Emerson 3MV Volume VentilatorCBK · Traditional | 12/15/1986SE |
| K864394 | Emerson 3MV Volume Ventilator · Traditional | 12/05/1986SE |
Questions and answers
When was Emerson In-Exsufflator, Models 2-CM & 2-CA cleared by the FDA?
Emerson In-Exsufflator, Models 2-CM & 2-CA (K924174) received a 510(k) decision of Substantially Equivalent on November 17, 1992, 90 days after the submission was received.
What is the product code of K924174?
The FDA product code is NHJ – Device, Positive Pressure Breathing, Intermittent, a Class II (moderate risk) device regulated under 21 CFR 868.5905.