Edentec Model 3710 I Digital Printer
FDA 510(k) K921819 · Edentec Corp.
510(k) numberK921819
Submission
- Device name
- Edentec Model 3710 I Digital Printer
- Applicant
- Edentec Corp.
Eden Prairie, MN, US - Received
- April 15, 1992
- Decision date
- October 22, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BZQ – Monitor, Breathing Frequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2375
- Specialty
- Anesthesiology
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Questions and answers
When was Edentec Model 3710 I Digital Printer cleared by the FDA?
Edentec Model 3710 I Digital Printer (K921819) received a 510(k) decision of Substantially Equivalent on October 22, 1993, 555 days after the submission was received.
What is the product code of K921819?
The FDA product code is BZQ – Monitor, Breathing Frequency, a Class II (moderate risk) device regulated under 21 CFR 868.2375.