1ST RESPONSE DISPOSABLE MANOMETER

Monitor, Airway Pressure (includes Gauge And/or Alarm)

INTERTECH RESOURCES, INC.

The following data is part of a premarket notification filed by Intertech Resources, Inc. with the FDA for 1st Response Disposable Manometer.

Pre-market Notification Details

Device IDK961318
510k NumberK961318
Device Name:1ST RESPONSE DISPOSABLE MANOMETER
ClassificationMonitor, Airway Pressure (includes Gauge And/or Alarm)
Applicant INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers,  FL  33905
ContactAvia Toney, Rac
CorrespondentAvia Toney, Rac
INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers,  FL  33905
Product CodeCAP  
CFR Regulation Number868.2600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-04-05
Decision Date1996-12-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
35019315059876 K961318 000
35019315059869 K961318 000
10889942314355 K961318 000
10889942303953 K961318 000
10889942290673 K961318 000
10889942290666 K961318 000
10889942290529 K961318 000
10889942290512 K961318 000
30351688428350 K961318 000

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