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

Rishon LeTziyon Central, IL

PeriGen Solutions Ltd. appears in FDA device records in Rishon LeTziyon Central, IL. FDA records list 2 510(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
2
PMA records
0
Recall records
1
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to PeriGen Solutions Ltd. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Lms Medical Systems , Ltd.510(k), recall

510(k) clearance history

FDA records hold 2 510(k) clearances for PeriGen Solutions Ltd. between 1998 and 2005. The busiest year on record is 1998, with 1. The most recent is 2005, with 1.

Clearances by year, as a table
510(k) clearance decisions for PeriGen Solutions Ltd., by decision year
YearClearances
19981
20051
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K040788CALM PATTERNS, VERSION 01.00.00HGMSubstantially Equivalent
K980719CALMHGMSubstantially Equivalent

Registered establishments

FDA registered establishments for PeriGen Solutions Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96153963002687025PeriGen Solutions Ltd.Azriel Rishonim, 10th Floor, Sderot Nim2, Rishon LeTziyon Central 7510002 IL2026

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-0821-06CALM software, version 02.09.01 This software is intended for use as a central monitoring system with signal analysis and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.A deficiency in the software code can, in certain circumstances, cause data for the wrong patient to be displayed in the Tracing Review screen when a user is acknowledging an AlertTerminated

Verification record

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