MODEL 520A NOVAMETRIX PULSE OXIMETER
FDA 510(k) clearance K913516 · decided 1991-11-04
Clearance details
- K-number
- K913516
- Device name
- MODEL 520A NOVAMETRIX PULSE OXIMETER
- Applicant
- Novametrix Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-08-07
- Decision date
- 1991-11-04
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Wallingford, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 100-120V Oxypleth - 520A Pulse Oximeter - Dixtal owned product. Intended use is to provide recall (Z-1295-2010) | Philips Healthcare Inc. | 2010-04-08 |
| Japanese 100-120V Oxypleth - 520A Pulse Oximeter- Dixtal owned product. Intended use is to recall (Z-1296-2010) | Philips Healthcare Inc. | 2010-04-08 |
| Span 100-120V 520A - OxyPleth Pulse Oximeter - Dixtal owned product. Intended use is to pr recall (Z-1297-2010) | Philips Healthcare Inc. | 2010-04-08 |
| 100-120V Oxypleth - 520A Pulse Oximeter, Refurbished - Dixtal owned product. Intended use recall (Z-1305-2010) | Philips Healthcare Inc. | 2010-04-08 |
| Dixtal Novametrix Neonatal/Pediatric SpO2 Sensor, Foam Wrap Style Catalog #: 6480-25. The recall (Z-1559-2009) | Dixtal Medical, Inc. | 2009-06-28 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TCO2M MODEL 818 MONITOR (P810022/S014) | Novametrix Medical Systems, Inc. | 1987-10-09 |
| TCO2M MODEL 818 MONITOR (P810022/S013) | Novametrix Medical Systems, Inc. | 1987-01-29 |
| TCO2M MODEL 818 MONITOR (P810022/S012) | Novametrix Medical Systems, Inc. | 1986-06-05 |
| TCO2M MODEL 818 MONITOR (P810022/S011) | Novametrix Medical Systems, Inc. | 1985-11-21 |
| TCO2M MODEL 818 MONITOR (P810022/S009) | Novametrix Medical Systems, Inc. | 1985-09-03 |
| TCO2M MODEL 818 MONITOR (P810022/S010) | Novametrix Medical Systems, Inc. | 1985-07-01 |
| TCO2M MODEL 818 MONITOR (P810022/S008) | Novametrix Medical Systems, Inc. | 1985-03-11 |
| TCO2M MODEL 818 MONITOR (P810022/S007) | Novametrix Medical Systems, Inc. | 1984-12-04 |