IBM 5885 Digital ECG Acquisition Cart
FDA 510(k) K810988 · Intl. Business Machines
510(k) numberK810988
Submission
- Device name
- IBM 5885 Digital ECG Acquisition Cart
- Applicant
- Intl. Business Machines
Mchenry, IL, US - Received
- April 13, 1981
- Decision date
- May 1, 1981
- 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 |
|---|---|---|
| K831004 | Automated 8400 Blood Cell SeparatorLKN · Traditional | 09/12/1983SE |
| K830163 | IBM 588 Digital ECG Acquisition/AnalysisDSI · Traditional | 02/18/1983SE |
| K812355 | IBM 2991 Blood Cell Processor Mod. 1 & 2CAC · Traditional | 09/09/1981SE |
| K810989 | IBM 5880 Acquisition & Analysis Cart TelLOS · Traditional | 05/01/1981SE |
| K772353 | EKG Acquisition & Analysis CartLOS · Traditional | 01/06/1978SE |
| K771258 | Blood Cell Separator 2997GKT · Traditional | 09/06/1977SE |
| K760856 | Blood Cell Processor Model 2 IBM 2991GKT · Traditional | 01/10/1977SE |
Questions and answers
When was IBM 5885 Digital ECG Acquisition Cart cleared by the FDA?
IBM 5885 Digital ECG Acquisition Cart (K810988) received a 510(k) decision of Substantially Equivalent on May 1, 1981, 18 days after the submission was received.
What is the product code of K810988?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.