Lsu 2000 Portable Suction Unit
FDA 510(k) K950698 · Laerdal Medical Corp.
510(k) numberK950698
Submission
- Device name
- Lsu 2000 Portable Suction Unit
- Applicant
- Laerdal Medical Corp.
Armonk, NY, US - Received
- February 10, 1995
- Decision date
- May 9, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Lsu 2000 Portable Suction Unit cleared by the FDA?
Lsu 2000 Portable Suction Unit (K950698) received a 510(k) decision of Substantially Equivalent on May 9, 1995, 88 days after the submission was received.
What is the product code of K950698?
The FDA product code is JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 878.4780.