510(k) K130170
- Device
- EXSPIRON 1XI
- Applicant
- RESPIRATORY MOTION, INC.
- 510(k) number
- K130170
- Product code
- BZK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-05-29
- Date received
- 2013-01-24
- Regulation
- 868.1850
- Classification name
- Spirometer, Monitoring (w/wo Alarm)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JENNY FREEMAN, MD
- Address
- 411 Waverly Oaks Rd., Bldg. 1, Suite 150 Waltham MA US 02452 02452
FDA Registration Numbers#
- 9710602
- 3007603826
- 3008264255
- 2430863
- 3013596024
- 3013500228
- 3016490024
- 2022648
- 3009156722
- 3013679558
- 3023272766
- 8043316
- 3006783791
- 1651104
- 3003971136
- 3006254047
- 3006606827
- 3030446844
- 3009499478
- 3016618143
- 3013853674
- 3005877899
- 3021559257
- 3008483389
- 2024500
- 3008729547
- 3017200972
- 1000604079
- 3004415070
- 3005783425
- 1722070
- 9610105
- 3018783526
- 3013557562
- 3000126629
- 3016509761
- 1219324
Source Documents#
Other 510(k) Records For Product Code BZK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192584 | BEACON Caresystem Model 00002144 | Mermaid Care A/S | 2019-12-18 |
| K192595 | ExSpiron 2Xi | Respiratory Motion | 2019-12-17 |
| K180788 | Gas Module 3 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-10-24 |
| K173181 | ExSpiron 1Xi | Respiratory Motion, Inc. | 2018-03-16 |
| K162131 | ExSpiron 1Xi | Respiratory Motion, Inc. | 2017-05-09 |
| K120087 | EXSPIRON | Respiratory Motion, Inc. | 2012-09-26 |
| K103578 | PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST | Respironics Novametrix, LLC | 2011-06-02 |
| K091853 | WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014 | Nspire Health, Inc. | 2009-09-21 |
| K092217 | MERCURY VCO2 | Respironics Novametrix, Inc. | 2009-08-21 |
| K091459 | PHILIPS NM3 MONITOR, MODEL 7900 | Respironics Novametrix, LLC | 2009-07-28 |
| K080652 | MERCURY VCO2 MODULE WITH CAPNOSTAT 5 | Respironics Novametrix, LLC | 2008-06-20 |
| K062754 | GAS MODULE SE, MODEL 0998-00-0481-02 | Datascope Corp. | 2006-11-02 |
| K051279 | CALDYNE, INC. EXHALOMETER EX100, MODEL EX100 | Caldyne, Inc. | 2005-09-07 |
| K983274 | STARTRACK INFANT GRAPHICS MONITOR | Nellcor Puritan Bennett, Inc. | 1998-12-09 |
| K972086 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311 | Alexander Mfg. Co. | 1997-08-12 |
Legacy Summary#
summary
FDA Review#
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