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

Andover, MA, US

NDD MEDICAL TECHNOLOGIES, INC. appears in FDA device records in Andover, MA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
2
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to NDD Medical Technologies, Inc. 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.

  • NDDd Medical Technologies, Inc.enforcement report, recall

510(k) clearance history

FDA records hold 1 510(k) clearance for NDD Medical Technologies, Inc. in 2000.

Clearances by year, as a table
510(k) clearance decisions for NDD Medical Technologies, Inc., by decision year
YearClearances
20001
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K993921NDD MEDICAL TECHNOLOGIES EASYONE SPIROMETER: FRONTLINE MODEL 2000 AND DIAGNOSTIC MODEL 2001BZGSubstantially Equivalent

Registered establishments

FDA registered establishments for NDD Medical Technologies, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
12264853002918917NDD MEDICAL TECHNOLOGIES, INC.300 BRICKSTONE SQ STE 604, ANDOVER, MA 01810 US2026No device listings on this registration

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-0597-2020EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1The CO/CO2 sensor cable harness may have lower electromagnetic shielding, which might have resulted in a non-compliance with the IEC 60601-1-2 standard. As a consequence of a lower electromagnetic shielding provided by the cable harness, the CO/CO2 sensor could have been influenced by high frequencies emitted by very close devices.Class IITerminated
Z-0596-2020EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1The CO/CO2 sensor cable harness may have lower electromagnetic shielding, which might have resulted in a non-compliance with the IEC 60601-1-2 standard. As a consequence of a lower electromagnetic shielding provided by the cable harness, the CO/CO2 sensor could have been influenced by high frequencies emitted by very close devices.Class IITerminated

Verification record

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