H-SCRIBE
FDA 510(k) clearance K004017 · decided 2001-06-11
Clearance details
- K-number
- K004017
- Device name
- H-SCRIBE
- Applicant
- Mortara Instrument, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-12-27
- Decision date
- 2001-06-11
- Days to decision
- 166 days
- Clearance type
- Traditional
- Product code
- MLO
- Device class
- 2
- Regulation number
- 870.2800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Mortara Instrument
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Philips Holter Analysis System (K241890) | Philips Medizin Systeme Böblingen GmbH | 2025-03-21 |
| Frontier X Plus (K240794) | Fourth Frontier Technologies Pvt, Ltd. | 2024-11-08 |
| RX-1 Rhythm Express Remote Cardiac Monitoring System (K200833) | VivaQuant, Inc. | 2020-09-02 |
| CER-S (K193177) | Cardiocalm | 2020-08-26 |
| Faros Mobile (K182030) | Bittium Biosignals , Ltd. | 2018-11-08 |
| CARDIOSPY ECG HOLTER SYSTEMS (K140847) | Labtech Kft. | 2014-12-05 |
| CV3000 HOLTER ANALYSIS SYSTEM (K131897) | Vales & Hills Biomedical Tech. , Ltd. | 2013-11-26 |
| AUDICOR CPAM WITH SDB (SINGLE SENSOR) (K130660) | Inovise Medical, Inc. | 2013-10-11 |
| AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) (K120462) | Inovise Medical, Inc. | 2012-09-20 |
| NH-301 AMBULATORY ECG ANALYSIS SOFTWARE (K111487) | Norav Medical Corp. | 2011-11-10 |
| AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) (K110569) | Inovise Medical, Inc. | 2011-10-24 |
| DYNAMIC ECG SYSTEM MODEL TLC5000 (K101273) | Contec Medical System Co., Ltd. | 2011-09-30 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring recall (Z-0320-2025) | Baxter Healthcare Corporation | 2024-11-07 |
| Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph recall (Z-0323-2025) | Baxter Healthcare Corporation | 2024-11-07 |