510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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AirStrip Technologies, Inc.

San Antonio, TX, US

AirStrip Technologies, Inc. appears in FDA device records in San Antonio, TX. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
15
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 15 510(k) clearances for AirStrip Technologies, Inc. between 2009 and 2021. The busiest year on record is 2012, with 3. The most recent is 2021, with 1.

Clearances by year, as a table
510(k) clearance decisions for AirStrip Technologies, Inc., by decision year
YearClearances
20092
20101
20112
20123
20131
20142
20151
20161
20181
20211
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K211949AirStrip ONE Web Client with Alarm Communication Management (ACM)MSXSubstantially Equivalent
K182226AirStrip RPM InvisionHeart AdapterMWISubstantially Equivalent
K160862AirStrip RPMMSXSubstantially Equivalent
K143114Sense4Baby System Model B+ (MSA)LQKSubstantially Equivalent
K133450AIRSTRIP REMOTE PATIENT MONITORINGMWISubstantially Equivalent
K133394AIRSTRIP REMOTE PATIENT MONITORINGMWISubstantially Equivalent
K131786AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTERMWISubstantially Equivalent
K121712AIRSTRIP RPM FOR LIFENET CONSULTMSXSubstantially Equivalent
K122133AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWINGMWISubstantially Equivalent
K121871AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWINGMWISubstantially Equivalent
K112235AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWINGMWISubstantially Equivalent
K110503AIRSTRIP REMOTE PATIENT MONITORING (RPM)MWISubstantially Equivalent
K100133AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1MWISubstantially Equivalent
K090269AIRSTRIP OBHGMSubstantially Equivalent
K090061AIRSTRIP OBHGMSubstantially Equivalent

Registered establishments

FDA registered establishments for AirStrip Technologies, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30061041913006104191AirStrip Technologies, Inc.2915 W Bitters Rd., SAN ANTONIO, TX 78248 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2829-2016AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is indicated for monitoring of maternal and fetal physiologic parameters during the antepartum period. The Sense4Baby System is to be used by health care professionals or patients, by prescription or doctor s order, in hospitals, clinics, physicians offices, antepartum rooms, or outside a hospital or health care setting. The data interpretation is to be done by a health care professional.Belt clip may become detached causing electronic components to be exposed.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain