Poseidon Cardiac Monitoring System (PCMS)
FDA 510(k) K964408 · Instromedix, Inc.
510(k) numberK964408
Submission
- Device name
- Poseidon Cardiac Monitoring System (PCMS)
- Applicant
- Instromedix, Inc.
Hillsboro, OR, US - Received
- November 4, 1996
- Decision date
- July 23, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K010945 | Heartcard, Model 5258DXH · Traditional | 06/12/2001SE |
| K964036 | Cardiomagic 2000 SoftwareDXH · Traditional | 07/18/1997SE |
| K955060 | Accelerated Transmission ProtocolDXH · Traditional | 04/08/1996SE |
| K951096 | Lifesigns Receiving Cener 2000 Transtelephonic ReceiverDXH · Traditional | 01/16/1996SE |
| K945476 | Hearthwatch Iii(Tm)DXH · Traditional | 11/09/1995SE |
| K950003 | Cardiomagic(R) Software EnhancementsDXH · Traditional | 10/31/1995SE |
| K944362 | Heartcard Cardiac Event MonitorDXH · Traditional | 09/07/1995SE |
| K943931 | Carryall EnhancementsDXH · Traditional | 04/04/1995SE |
| K935586 | PrinceDXH · Traditional | 11/08/1994SE |
| K925639 | Cardiomagic SoftwareDXH · Traditional | 06/22/1993SE |
Questions and answers
When was Poseidon Cardiac Monitoring System (PCMS) cleared by the FDA?
Poseidon Cardiac Monitoring System (PCMS) (K964408) received a 510(k) decision of Substantially Equivalent on July 23, 1997, 261 days after the submission was received.
What is the product code of K964408?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.