Maximus System
FDA 510(k) K200988 · Hill-Rom Services Pte, Ltd.
510(k) numberK200988
Submission
- Device name
- Maximus System
- Applicant
- Hill-Rom Services Pte, Ltd.
Singapore, SG - Received
- April 15, 2020
- Decision date
- May 26, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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| 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 |
| 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 |
| K140605 | Minipegaso Cough, Minipegaso A-Cough, Minipegaso A-Coug PercNHJ · Traditional | Dima Italia Srl | 10/03/2014SE |
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Questions and answers
When was Maximus System cleared by the FDA?
Maximus System (K200988) received a 510(k) decision of Substantially Equivalent on May 26, 2020, 41 days after the submission was received.
What is the product code of K200988?
The FDA product code is NHJ – Device, Positive Pressure Breathing, Intermittent, a Class II (moderate risk) device regulated under 21 CFR 868.5905.