Vitalograph Model 7100 - Vitalojak
FDA 510(k) K110525 · Vitalograph (Ireland) , Ltd.
510(k) numberK110525
Submission
- Device name
- Vitalograph Model 7100 - Vitalojak
- Applicant
- Vitalograph (Ireland) , Ltd.
Ennis, Co. Clare, IE - Received
- February 23, 2011
- Decision date
- November 23, 2011
- 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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Questions and answers
When was Vitalograph Model 7100 - Vitalojak cleared by the FDA?
Vitalograph Model 7100 - Vitalojak (K110525) received a 510(k) decision of Substantially Equivalent on November 23, 2011, 273 days after the submission was received.
What is the product code of K110525?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.