ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR

Stethoscope, Esophageal, With Electrical Conductors

RESPIRATORY SUPPORT PRODUCTS, INC.

The following data is part of a premarket notification filed by Respiratory Support Products, Inc. with the FDA for Acoustascope Esophageal Stethoscope W/temp Sensor.

Pre-market Notification Details

Device IDK854212
510k NumberK854212
Device Name:ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR
ClassificationStethoscope, Esophageal, With Electrical Conductors
Applicant RESPIRATORY SUPPORT PRODUCTS, INC. 3183-D AIRWAY AVE. Costa Mesa,  CA  92626
ContactSteve Georgevich
CorrespondentSteve Georgevich
RESPIRATORY SUPPORT PRODUCTS, INC. 3183-D AIRWAY AVE. Costa Mesa,  CA  92626
Product CodeBZT  
CFR Regulation Number868.1920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-10-17
Decision Date1986-01-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10695085000372 K854212 000
10695085000266 K854212 000
10695085000273 K854212 000
10695085000280 K854212 000
10695085000297 K854212 000
10695085000303 K854212 000
10695085000310 K854212 000
10695085000327 K854212 000
10695085000334 K854212 000
10695085000358 K854212 000
10695085000365 K854212 000
35019517059209 K854212 000

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