Mcintosh, Miller, Foregger Baby
FDA 510(k) K945425 · Rudolf Riester GmbH & Co. KG
510(k) numberK945425
Submission
- Device name
- Mcintosh, Miller, Foregger Baby
- Applicant
- Rudolf Riester GmbH & Co. KG
D-72417 Jungingen, DE - Received
- November 4, 1994
- Decision date
- March 20, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CCW – Laryngoscope, Rigid
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5540
- Specialty
- Anesthesiology
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Questions and answers
When was Mcintosh, Miller, Foregger Baby cleared by the FDA?
Mcintosh, Miller, Foregger Baby (K945425) received a 510(k) decision of Substantially Equivalent on March 20, 1995, 136 days after the submission was received.
What is the product code of K945425?
The FDA product code is CCW – Laryngoscope, Rigid, a Class I (low risk) device regulated under 21 CFR 868.5540.