BODYTRODE
FDA 510(k) clearance K961288 · decided 1996-08-08
Clearance details
- K-number
- K961288
- Device name
- BODYTRODE
- Applicant
- Marquette Electronics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-04-04
- Decision date
- 1996-08-08
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- DRX
- Device class
- 2
- Regulation number
- 870.2360
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Jupiter, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Marquette Electronics
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 |
|---|---|---|
| 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.