Cardiolight
FDA 510(k) K982448 · Capintec, Inc.
510(k) numberK982448
Submission
- Device name
- Cardiolight
- Applicant
- Capintec, Inc.
Pittsburgh, PA, US - Received
- July 15, 1998
- Decision date
- June 11, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K020150 | CRC-15BTKPT · Traditional | 08/02/2002SE |
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Questions and answers
When was Cardiolight cleared by the FDA?
Cardiolight (K982448) received a 510(k) decision of Substantially Equivalent on June 11, 1999, 331 days after the submission was received.
What is the product code of K982448?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.