SIRECUST 358
FDA 510(k) clearance K803208 · decided 1981-05-27
Clearance details
- K-number
- K803208
- Device name
- SIRECUST 358
- Applicant
- Siemens Corp.
- Decision
- Substantially Equivalent
- Date received
- 1980-12-18
- Decision date
- 1981-05-27
- Days to decision
- 160 days
- Clearance type
- Traditional
- Product code
- DSI
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, 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 |
|---|---|---|
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| SmartCardia 7L Platform (K231276) | Smartcardia SA | 2023-08-30 |
| Unified Arrhythmia Diagnostic System PocketECG IV (K193104) | Medicalgorithmics S.A. | 2020-04-09 |
| BodyGuardian Remote Monitoring System (K192732) | Preventice Technologies, Inc. | 2020-03-26 |
| Patient Assistant Model PA97000 (K190574) | Medtronic, Inc. | 2019-09-24 |
| Liba3 System (K182532) | National Cardiac, Inc. | 2019-05-15 |
| MobileECG 2 BT (K181658) | Memtec Corporation | 2019-03-26 |
| Medicalgorithmics Unified Cardiac Rehabilitation System (K173969) | Medicalgorithmics S.A. | 2018-07-11 |
| Epicardia Anywhere (K173170) | Medicomp, Inc. | 2018-01-10 |
Recalls involving this device
No recalls on record reference this clearance.