Gikter ECG Cassette Tape Recorder Model XR 300
FDA 510(k) K921068 · Datrix
510(k) numberK921068
Submission
- Device name
- Gikter ECG Cassette Tape Recorder Model XR 300
- Applicant
- Datrix
Escondido, CA, US - Received
- March 6, 1992
- Decision date
- March 30, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Gikter ECG Cassette Tape Recorder Model XR 300 cleared by the FDA?
Gikter ECG Cassette Tape Recorder Model XR 300 (K921068) received a 510(k) decision of Substantially Equivalent on March 30, 1992, 24 days after the submission was received.
What is the product code of K921068?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.