STARTRACK INFANT GRAPHICS MONITOR
FDA 510(k) clearance K983274 · decided 1998-12-09
Clearance details
- K-number
- K983274
- Device name
- STARTRACK INFANT GRAPHICS MONITOR
- Applicant
- Nellcor Puritan Bennett, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-09-17
- Decision date
- 1998-12-09
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- BZK
- Device class
- 2
- Regulation number
- 868.1850
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Lenexa, KS, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Nellcor Puritan Bennett
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NELLCOR PURITAN BENNETT INFANT STAR HIGH FREQUENCY VENTILATOR (P880013/S009) | Nellcor Puritan Bennett, Inc. | 2002-12-17 |
| HFV INFANT STAR VENTILATOR (P880013/S008) | Nellcor Puritan Bennett, Inc. | 1998-04-07 |
| HIGH FREQUENCY VENTILATOR (P880013/S007) | Nellcor Puritan Bennett, Inc. | 1997-06-24 |
| HFV STAR (P880013/S003) | Nellcor Puritan Bennett, Inc. | 1993-10-26 |
| HFV STAR (NEW MANUFACTURING SITE) (P880013/S002) | Nellcor Puritan Bennett, Inc. | 1993-08-11 |
| HFV STAR (P880013/S001) | Nellcor Puritan Bennett, Inc. | 1993-02-05 |
| INFANT STAR HIGH FREQUENCY VENTILATOR (P880013) | Nellcor Puritan Bennett, Inc. | 1990-01-19 |