510(k) K961116
- Device
- FIRST BEAT/CARDIO BEAT/CALC
- Applicant
- MEDASONICS, INC.
- 510(k) number
- K961116
- Product code
- IYO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-08-08
- Date received
- 1996-03-20
- Regulation
- 892.1560
- Classification name
- System, Imaging, Pulsed Echo, Ultrasonic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- WILLIAM E MCKAY
- Address
- 9712 S. Altamont Dr. Sandy UT US 84092 84092
FDA Registration Numbers
- 3002808148
- 2939830
- 1450662
- 3031397684
- 1319721
- 3031564213
- 1054713
- 3010457937
- 3011278898
- 1937397
- 3006260740
- 3011599810
- 1216677
- 2918630
- 3032367
- 3011411309
- 3010663777
- 3008487708
- 3011050570
- 3010390468
- 1319660
- 3017968993
- 3008950127
- 3008321254
- 3011416394
- 3010952312
- 3005810333
- 3025786376
- 3016171942
- 3003594449
- 3017406171
- 1066270
- 8043933
- 3014279513
- 3033508292
- 3007603826
- 9611343
- 3007015148
- 3012387143
- 3013041594
- 3040391009
- 3038718997
- 9612283
- 9610816
- 1450908
- 3003857828
- 3003600763
- 3011686611
- 3008223664
- 3005210579
- 3012198618
- 3012104670
- 2531814
- 3009756153
- 1000314502
- 2029275
- 2244725
- 3029744051
- 2936921
- 3008253300
- 3033275035
- 3007994837
- 3034286426
- 3006680097
- 3016271578
- 3033858858
- 3014639846
- 3032109225
- 3016493665
- 3014680735
- 9680671
- 3031158
- 1834003
- 9613067
- 9611031
- 3026047529
- 1224842
- 9611033
- 3006581049
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00888937002621 | MedaSonics | Coopersurgical, Inc. | 2016-07-18 |
| 00888937002614 | MedaSonics | Coopersurgical, Inc. | 2016-07-18 |
| 00888937002607 | MedaSonics | Coopersurgical, Inc. | 2016-07-18 |
| 00888937002591 | MedaSonics | Coopersurgical, Inc. | 2016-07-18 |
| 00888937002584 | MedaSonics | Coopersurgical, Inc. | 2016-07-18 |
| 00888937002577 | MedaSonics | Coopersurgical, Inc. | 2016-07-18 |
| 00888937002560 | MedaSonics | Coopersurgical, Inc. | 2016-07-18 |
| 00888937002553 | MedaSonics | Coopersurgical, Inc. | 2016-07-18 |
| 00888937002546 | MedaSonics | Coopersurgical, Inc. | 2016-07-18 |
| 00888937002539 | MedaSonics | Coopersurgical, Inc. | 2016-07-18 |
| 00888937002522 | MedaSonics | Coopersurgical, Inc. | 2016-07-18 |
| 00888937002515 | MedaSonics | Coopersurgical, Inc. | 2016-07-18 |
| 00888937002508 | MedaSonics | Coopersurgical, Inc. | 2016-07-18 |
Legacy Summary
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases