PHYSIOLOGICAL PRESSURE MEASUREMENT SYS
FDA 510(k) clearance K830638 · decided 1983-04-18
Clearance details
- K-number
- K830638
- Device name
- PHYSIOLOGICAL PRESSURE MEASUREMENT SYS
- Applicant
- Camino Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-01
- Decision date
- 1983-04-18
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- DXO
- Device class
- 2
- Regulation number
- 870.2870
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Walker, MI, 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 |
|---|---|---|
| OptoMonitor 3 (K251367) | Opsens, Inc. | 2026-01-16 |
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| TruWave Disposable Pressure Transducer (K222216) | Edwards Lifesciences, LLC | 2022-12-22 |
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| OptoMonitor 3 (K193620) | Opsens, Inc. | 2020-06-18 |
| Comet II Pressure Guidewire (K193279) | Boston Scientific Corporation | 2019-12-23 |
| OptoMonitor (K192340) | Opsens, Inc. | 2019-12-12 |
| Zurich Pressure Guidewire System Model 100 (K190852) | Zurich Medical, Inc. | 2019-08-14 |
| TruWave Disposable Pressure Transducer (K183413) | Edwards Lifeciences, LLC | 2019-05-01 |
| PressureWire X (K180558) | St. Jude Medical (Now Part of Abbott Medical) | 2018-03-28 |
| TruWave Disposable Pressure Transducer (K171996) | Edwards Lifesciences, LLC | 2017-10-23 |
Recalls involving this device
No recalls on record reference this clearance.