Vitalograph 2110 Software Interface
FDA 510(k) K950854 · Vitalograph , Ltd.
510(k) numberK950854
Submission
- Device name
- Vitalograph 2110 Software Interface
- Applicant
- Vitalograph , Ltd.
Lenexa, KS, US - Received
- February 27, 1995
- Decision date
- October 12, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSH – Recorder, Magnetic Tape, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
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More from Bardy Diagnostics, Inc.
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| K253293 | VitaloJAK Clinic (Model 7100)DSH · Special | 12/03/2025SE |
| K000599 | Vitalograph Base StationBZG · Traditional | 09/08/2000SE |
| K991412 | Vitalograph MicroBZH · Traditional | 02/04/2000SE |
| K943678 | Electronic Flow MeterBZH · Traditional | 12/14/1995SE |
| K946075 | Vitalograph Model 2120BZG · Traditional | 08/04/1995SE |
| K942779 | Disposable Bacteriological FilterBZG · Traditional | 07/13/1994SE |
| K925085 | Escort SpirometerBZG · Traditional | 08/12/1993SE |
| K930085 | Vitalograph Data Storage SpirometerBTY · Traditional | 07/26/1993SE |
| K912412 | Vitalograph Spirotrac IIIBZG · Traditional | 10/15/1991SE |
| K893665 | Aerosol Inhalation MonitorBWF · Traditional | 08/21/1989SE |
Questions and answers
When was Vitalograph 2110 Software Interface cleared by the FDA?
Vitalograph 2110 Software Interface (K950854) received a 510(k) decision of Substantially Equivalent on October 12, 1995, 227 days after the submission was received.
What is the product code of K950854?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.