510(k) K030316
- Device
- AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR)
- Applicant
- Inovise Medical, Inc.
- 510(k) number
- K030316
- Product code
- DRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-08-07
- Date received
- 2003-01-30
- Regulation
- 870.2360
- Classification name
- Electrode, Electrocardiograph
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Y
Applicant Contact#
- Contact
- KENDRA RATHKEY
- Address
- 1025 Industrial Pkwy. Suite C Newberg OR US 97132 97132
FDA Registration Numbers#
- 3021219789
- 3022568093
- 3034669683
- 3008717264
- 2031094
- 3030447506
- 3030626857
- 3004531359
- 9680794
- 3038181770
- 2427500
- 1625392
- 3036470679
- 2025066
- 3014848734
- 3016096058
- 3000126629
- 3003749270
- 3009555600
- 3014111150
- 3007734888
- 2434982
- 3012606445
- 3010131466
- 3011787398
- 3007048259
- 3008114669
- 3010131137
- 3013873578
- 3023164
- 3008617703
- 3011391433
- 8043459
- 3014437893
- 3023272766
- 1531159
- 2025694
- 3001124136
- 2245574
- 2320762
- 3007748793
- 3022298579
- 2133585
- 2124215
- 3014233600
- 3016566173
- 3005273623
- 3017425211
- 9613910
- 3042888450
- 3029901632
- 9681860
- 3013426279
- 3009883402
- 3003965134
- 3018783526
- 2438852
- 3004537821
- 3011307234
- 1219103
- 3013681758
- 3000947648
- 2183164
- 3013684844
- 1223925
- 3006227741
- 3043226252
- 3013522941
- 3007184699
- 3010419931
- 3006626283
- 9610691
- 2022388
- 3016678045
- 3038988287
- 1043214
- 1030451
- 3008933393
- 3012421607
Source Documents#
Other 510(k) Records For Product Code DRX#
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|---|---|---|---|
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| K123658 | BIOMODULE 3-M1 | Zephyr Technology Corporation | 2013-04-24 |
| K101576 | CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES | Team Innovations, Inc. | 2010-07-22 |
| K101685 | IP-SET | Integral Process Sas | 2010-07-01 |
| K100129 | AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X | Ambu A/S | 2010-06-11 |
| K093327 | INTCO TAB ELECTRODE | Shanghai Intco Electrode Manufacturing Co., Ltd. | 2010-05-10 |
| K100315 | 12 LEAD GLOVE | I Needmd, Inc. | 2010-04-23 |
| K092744 | NEONATAL ECG ELECTRODE, M203KEN | R & D Medical Products, Inc. | 2009-12-10 |
| K092389 | DISPOSAL ECG ELECTRODES, MODEL EASYRODE | Suzuken Co., Ltd. | 2009-10-13 |
| K090496 | QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH | Cardiac Lead Technologies, Inc. | 2009-09-01 |
| K092291 | SKINTACT AND VARIOUS OTHER TRADENAMES | Leonhard Lang GmbH | 2009-08-21 |
| K091856 | CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES | Conmed Corporation | 2009-08-07 |
| K090180 | TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE | Vermed, Inc. | 2009-06-17 |
| K083677 | PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 | Commwell , Ltd. | 2009-03-10 |