Passport 5L-CE Model 0998-00-0131XXX
FDA 510(k) K974178 · Datascope Corp.
510(k) numberK974178
Submission
- Device name
- Passport 5L-CE Model 0998-00-0131XXX
- Applicant
- Datascope Corp.
Paramus, NJ, US - Received
- November 6, 1997
- Decision date
- June 26, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
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Questions and answers
When was Passport 5L-CE Model 0998-00-0131XXX cleared by the FDA?
Passport 5L-CE Model 0998-00-0131XXX (K974178) received a 510(k) decision of Substantially Equivalent on June 26, 1998, 232 days after the submission was received.
What is the product code of K974178?
The FDA product code is DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II (moderate risk) device regulated under 21 CFR 870.2300.