ExSpiron 1Xi
FDA 510(k) K162131 · Respiratory Motion, Inc.
510(k) numberK162131
Submission
- Device name
- ExSpiron 1Xi
- Applicant
- Respiratory Motion, Inc.
Waltham, MA, US - Received
- August 1, 2016
- Decision date
- May 9, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZK – Spirometer, Monitoring (W/Wo Alarm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1850
- Specialty
- Anesthesiology
Other 510(k)s with product code BZK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192584 | BEACON Caresystem Model 00002144BZK · Traditional | Mermaid Care A/S | 12/18/2019SE |
| K192595 | ExSpiron 2XiBZK · Special | Respiratory Motion | 12/17/2019SE |
| K180788 | Gas Module 3BZK · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 10/24/2018SE |
| K173181 | ExSpiron 1XiBZK · Traditional | Respiratory Motion, Inc. | 03/16/2018SE |
| K130170 | Exspiron 1XIBZK · Special | Respiratory Motion, Inc. | 05/29/2013SE |
| K120087 | ExspironBZK · Traditional | Respiratory Motion, Inc. | 09/26/2012SE |
| K103578 | Philips NM3 Respiratory Monitor with VentassistBZK · Traditional | Respironics Novametrix, LLC | 06/02/2011SE |
| K091853 | Wright Respirometer, Mark 8, and 14 Respirometer, Model 700-021, 700-008, 700-014BZK · Traditional | Nspire Health, Inc. | 09/21/2009SE |
| K092217 | Mercury VCO2BZK · Special | Respironics Novametrix, Inc. | 08/21/2009SE |
| K091459 | Philips NM3 Monitor, Model 7900BZK · Special | Respironics Novametrix, LLC | 07/28/2009SE |
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Questions and answers
When was ExSpiron 1Xi cleared by the FDA?
ExSpiron 1Xi (K162131) received a 510(k) decision of Substantially Equivalent on May 9, 2017, 281 days after the submission was received.
What is the product code of K162131?
The FDA product code is BZK – Spirometer, Monitoring (W/Wo Alarm), a Class II (moderate risk) device regulated under 21 CFR 868.1850.