CASSETTE READER
FDA 510(k) clearance K811253 · decided 1981-07-10
Clearance details
- K-number
- K811253
- Device name
- CASSETTE READER
- Applicant
- American Edwards Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1981-05-05
- Decision date
- 1981-07-10
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- DSH
- Device class
- 2
- Regulation number
- 870.2800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| LifeLens Physiological Monitor (K260157) | LifeLens Technologies, Inc. | 2026-07-09 |
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| AeviceMD (K243603) | Aevice Health Pte. , Ltd. | 2025-05-05 |
| AT-Patch (ATP-C130/ATP-C70) (K242583) | Atsens Co., Ltd. | 2025-05-02 |
| HiCardi+ H100 (K232670) | MEZOO Co., Ltd. | 2024-09-20 |
| S-Patch (S-Patch ExL) (K233906) | Wellysis Corp. | 2024-02-16 |
| ABPMpro (K231104) | Somnomedics GmbH | 2023-11-27 |
| Carnation Ambulatory Monitor (K233110) | Bardy Diagnostics, Inc. | 2023-11-22 |
| Holter ECG and ABP System (K230184) | Edan Instruments, Inc. | 2023-09-25 |
| S-Patch Ex Wearable ECG Patch (K231289) | Wellysis Corp. | 2023-08-30 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GARREN GASTRIC BUBBLE (P840025/S011) | American Edwards Laboratories | 1987-03-17 |
| GARREN GASTRIC BUBBLE (P840025/S008) | American Edwards Laboratories | 1986-10-16 |
| GARREN GASTRIC BUBBLE (P840025/S006) | American Edwards Laboratories | 1986-07-25 |
| GARREN{TM}-EDWARDS GASTRIC BUBBLE (P840025/S005) | American Edwards Laboratories | 1986-05-12 |
| GARREN GASTRIC BUBBLE (P840025/S003) | American Edwards Laboratories | 1986-01-23 |
| GARREN GASTRIC BUBBLE (P840025/S002) | American Edwards Laboratories | 1986-01-23 |
| GARREN GASTRIC BUBBLE (P840025/S004) | American Edwards Laboratories | 1986-01-23 |
| GARREN GASTRIC BUBBLE (P840025/S001) | American Edwards Laboratories | 1985-12-18 |