RX Aspen
FDA 510(k) K882170 · Jeneric/Pentron, Inc.
510(k) numberK882170
Submission
- Device name
- RX Aspen
- Applicant
- Jeneric/Pentron, Inc.
Wallingford, CT, US - Received
- May 24, 1988
- Decision date
- June 17, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was RX Aspen cleared by the FDA?
RX Aspen (K882170) received a 510(k) decision of Substantially Equivalent on June 17, 1988, 24 days after the submission was received.
What is the product code of K882170?
The FDA product code is EJH – Alloy, Metal, Base, a Class II (moderate risk) device regulated under 21 CFR 872.3710.