MetaNeb 4 System
FDA 510(k) K151689 · Hill-Rom Services Pte, Ltd.
510(k) numberK151689
Submission
- Device name
- MetaNeb 4 System
- Applicant
- Hill-Rom Services Pte, Ltd.
Singapore, SG - Received
- June 23, 2015
- Decision date
- March 17, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| K140598 | Pegaso Cough, Pegaso A-Cough, Pegaso A-Cough PercNHJ · Traditional | Dima Italia Srl | 10/16/2014SE |
| K140605 | Minipegaso Cough, Minipegaso A-Cough, Minipegaso A-Coug PercNHJ · Traditional | Dima Italia Srl | 10/03/2014SE |
More from Dima Italia Srl
Questions and answers
When was MetaNeb 4 System cleared by the FDA?
MetaNeb 4 System (K151689) received a 510(k) decision of Substantially Equivalent on March 17, 2016, 268 days after the submission was received.
What is the product code of K151689?
The FDA product code is NHJ – Device, Positive Pressure Breathing, Intermittent, a Class II (moderate risk) device regulated under 21 CFR 868.5905.