510(k) Report

Devices descending from K131994

5 later devices reach Somnolyzer 24X7 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142988Sleepware G3Respironics, Inc.20154—
+2K250851Hypnos (369054-200)Cadwell Industries, Inc.20250—
+2K202142Sleepware G3Respironics, Inc.20202—
+3K241960DeepRESPNox Medical Ehf20251—
+4K252330DeepRESPNox Medical Ehf20250—