35MM Angiogram Viewer Analyzer
FDA 510(k) K821491 · Birtcher Corp.
510(k) numberK821491
Submission
- Device name
- 35MM Angiogram Viewer Analyzer
- Applicant
- Birtcher Corp.
Mchenry, IL, US - Received
- May 18, 1982
- Decision date
- July 8, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXJ – Display, Cathode-Ray Tube, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2450
- Specialty
- Cardiovascular
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| K850668 | Electrosurgical Unit 774GEI · Traditional | 05/20/1985SE |
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Questions and answers
When was 35MM Angiogram Viewer Analyzer cleared by the FDA?
35MM Angiogram Viewer Analyzer (K821491) received a 510(k) decision of Substantially Equivalent on July 8, 1982, 51 days after the submission was received.
What is the product code of K821491?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.