ELECTRODE, DEIP.
FDA 510(k) clearance K781163 · decided 1978-09-26
Clearance details
- K-number
- K781163
- Device name
- ELECTRODE, DEIP.
- Applicant
- Datascope Corp.
- Decision
- Substantially Equivalent
- Date received
- 1978-07-12
- Decision date
- 1978-09-26
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- DRX
- Device class
- 2
- Regulation number
- 870.2360
- 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 |
|---|---|---|
| Physiotrace (K171244) | Nimbleheart, Inc. | 2017-08-23 |
| HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE (K140096) | Hmicro, Inc. | 2014-07-24 |
| BIOMODULE 3-M1 (K123658) | Zephyr Technology Corporation | 2013-04-24 |
| CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES (K101576) | Team Innovations, Inc. | 2010-07-22 |
| IP-SET (K101685) | Integral Process Sas | 2010-07-01 |
| AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X (K100129) | Ambu A/S | 2010-06-11 |
| INTCO TAB ELECTRODE (K093327) | Shanghai Intco Electrode Manufacturing Co., Ltd. | 2010-05-10 |
| 12 LEAD GLOVE (K100315) | I Needmd, Inc. | 2010-04-23 |
| NEONATAL ECG ELECTRODE, M203KEN (K092744) | R & D Medical Products, Inc. | 2009-12-10 |
| DISPOSAL ECG ELECTRODES, MODEL EASYRODE (K092389) | Suzuken Co., Ltd. | 2009-10-13 |
| QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH (K090496) | Cardiac Lead Technologies, Inc. | 2009-09-01 |
| SKINTACT AND VARIOUS OTHER TRADENAMES (K092291) | Leonhard Lang GmbH | 2009-08-21 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ABSORBABLE COLLAGEN HEMOSTAT (P850023/S014) | Datascope Corp. | 1994-12-22 |
| HEMOPAD(TM) ABSORBABLE COLLAGEN HEMOSTAT (P850023/S010) | Datascope Corp. | 1992-11-16 |
| ABSORBABLE COLLAGEN HEMOSTAT (P850023/S013) | Datascope Corp. | 1992-08-26 |
| HEMAFLEX (TM) MED-CHEM PRODUCTS,DISTRIBUTOR (P850023/S011) | Datascope Corp. | 1991-10-04 |
| NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S009) | Datascope Corp. | 1990-09-28 |
| NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S005) | Datascope Corp. | 1989-05-17 |
| NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S008) | Datascope Corp. | 1989-03-09 |
| NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S006) | Datascope Corp. | 1988-09-09 |