Opus Pacemakers (Models 4021, 4033, and 4034)
FDA 510(k) K952363 · Ela Medical, Inc.
510(k) numberK952363
Submission
- Device name
- Opus Pacemakers (Models 4021, 4033, and 4034)
- Applicant
- Ela Medical, Inc.
Minnetonka, MN, US - Received
- May 1, 1995
- Decision date
- August 15, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Opus Pacemakers (Models 4021, 4033, and 4034) cleared by the FDA?
Opus Pacemakers (Models 4021, 4033, and 4034) (K952363) received a 510(k) decision of Substantially Equivalent on August 15, 1995, 106 days after the submission was received.
What is the product code of K952363?
The FDA product code is ELA – Instrument, Hand, Calculus Removal, a Class I (low risk) device regulated under 21 CFR 872.4565.