Danninger Trimcheck(Tm) Portable & Desk Top Models
FDA 510(k) K881841 · Buckman Co., Inc.
510(k) numberK881841
Submission
- Device name
- Danninger Trimcheck(Tm) Portable & Desk Top Models
- Applicant
- Buckman Co., Inc.
Martinez, CA, US - Received
- May 2, 1988
- Decision date
- December 13, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSB – Plethysmograph, Impedance
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2770
- Specialty
- Cardiovascular
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Questions and answers
When was Danninger Trimcheck(Tm) Portable & Desk Top Models cleared by the FDA?
Danninger Trimcheck(Tm) Portable & Desk Top Models (K881841) received a 510(k) decision of Substantially Equivalent on December 13, 1988, 225 days after the submission was received.
What is the product code of K881841?
The FDA product code is DSB – Plethysmograph, Impedance, a Class II (moderate risk) device regulated under 21 CFR 870.2770.