SERIES 7000/HOLTER RECORDER
FDA 510(k) clearance K851971 · decided 1985-06-20
Clearance details
- K-number
- K851971
- Device name
- SERIES 7000/HOLTER RECORDER
- Applicant
- Pfizer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-05-07
- Decision date
- 1985-06-20
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- DSH
- Device class
- 2
- Regulation number
- 870.2800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
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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 |
|---|---|---|
| GELFOAM (absorbable gelatin gel, powder from abs. gel, sponge USP), GELFOAM (compressed absorbable gelatin sponge, USP), (N18286/S041) | Pfizer, Inc. | 2023-05-16 |
| (Gelfoam (absorbable gelatin) Sterile Sponge) (N18286/S040) | Pfizer, Inc. | 2022-06-24 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S039) | Pfizer, Inc. | 2021-07-08 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S038) | Pfizer, Inc. | 2021-05-07 |
| Gelfoam Sterile Sponge (N18286/S037) | Pfizer, Inc. | 2021-02-24 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S036) | Pfizer, Inc. | 2020-12-10 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S035) | Pfizer, Inc. | 2020-03-19 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S034) | Pfizer, Inc. | 2020-02-27 |