RESPITRAK
FDA 510(k) clearance K884959 · decided 1989-06-08
Clearance details
- K-number
- K884959
- Device name
- RESPITRAK
- Applicant
- Non-Invasive Monitoring Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-11-29
- Decision date
- 1989-06-08
- Days to decision
- 191 days
- Clearance type
- Traditional
- Product code
- BZK
- Device class
- 2
- Regulation number
- 868.1850
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BEACON Caresystem Model 00002144 (K192584) | Mermaid Care A/S | 2019-12-18 |
| ExSpiron 2Xi (K192595) | Respiratory Motion | 2019-12-17 |
| Gas Module 3 (K180788) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-10-24 |
| ExSpiron 1Xi (K173181) | Respiratory Motion, Inc. | 2018-03-16 |
| ExSpiron 1Xi (K162131) | Respiratory Motion, Inc. | 2017-05-09 |
| EXSPIRON 1XI (K130170) | Respiratory Motion, Inc. | 2013-05-29 |
| EXSPIRON (K120087) | Respiratory Motion, Inc. | 2012-09-26 |
| PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST (K103578) | Respironics Novametrix, LLC | 2011-06-02 |
| WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014 (K091853) | Nspire Health, Inc. | 2009-09-21 |
| MERCURY VCO2 (K092217) | Respironics Novametrix, Inc. | 2009-08-21 |
| PHILIPS NM3 MONITOR, MODEL 7900 (K091459) | Respironics Novametrix, LLC | 2009-07-28 |
| MERCURY VCO2 MODULE WITH CAPNOSTAT 5 (K080652) | Respironics Novametrix, LLC | 2008-06-20 |
Recalls involving this device
No recalls on record reference this clearance.