Portascope II
FDA 510(k) K770832 · Mennen Greatbatch Electonics
510(k) numberK770832
Submission
- Device name
- Portascope II
- Applicant
- Mennen Greatbatch Electonics
Mchenry, IL, US - Received
- May 6, 1977
- Decision date
- June 3, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DPS – Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2340
- Specialty
- Cardiovascular
Other 510(k)s with product code DPS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)DPS · Traditional | Edan Instruments, Inc. | 07/02/2026SE |
| K251670 | MAC 7 Resting ECG Analysis SystemDPS · Traditional | Ge Medical Systems Information Technologies, Inc. | 01/26/2026SE |
| K252361 | AccurECG Analysis System (v2.0)DPS · Traditional | Accurkardia, Inc. | 12/22/2025SE |
| K252474 | Withings BeamO (SCT02)DPS · Traditional | Withings | 11/10/2025SE |
| K250569 | Cardiologs Holter PlatformDPS · Traditional | Philips France Commercial | 08/06/2025SE |
| K243252 | ZBPro DiagnosticDPS · Traditional | Zbeats, Inc. | 07/10/2025SE |
| K243305 | Masimo W1DPS · Traditional | Masimo Corporation | 04/03/2025SE |
| K241217 | CloudHRV System (100-01-001)DPS · Traditional | Inmedix, Inc. | 01/16/2025SE |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000)DPS · Traditional | Philips Medizin Systeme Böblingen GmbH | 12/17/2024SE |
| K240229 | Masimo W1DPS · Traditional | Masimo Corporation | 08/08/2024SE |
More from Masimo Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K772000 | ECG Telemetry SystemDRG · Traditional | 11/22/1977SE |
| K770279 | Monitor, Portable, Part #431-010DXJ · Traditional | 02/24/1977SE |
| K770247 | D.C. Amplifier ModuleDRQ · Traditional | 02/14/1977SE |
| K770246 | Isolated EEG Amplifier ModuleGWQ · Traditional | 02/14/1977SE |
| K770245 | Abdominal Fetal ECG ModuleKXN · Traditional | 02/14/1977SE |
Questions and answers
When was Portascope II cleared by the FDA?
Portascope II (K770832) received a 510(k) decision of Substantially Equivalent on June 3, 1977, 28 days after the submission was received.
What is the product code of K770832?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.