FDA 510(k)

BMLS16-1

K-Number: K172971 · 2018-07-08

Decision Date2018-07-08

Product CodeNUH

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

BMLS16-1 is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Life Systems, Inc.. It received FDA 510(k) clearance on 2018-07-08 under 510(k) number K172971. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BMLS16-1?

BMLS16-1 is a medical device that received FDA 510(k) clearance on 2018-07-08. The listed applicant is Biomedical Life Systems, Inc.. The 510(k) number is K172971.

When did BMLS16-1 receive FDA 510(k) clearance?

BMLS16-1 received FDA 510(k) clearance on 2018-07-08, under 510(k) number K172971.

Who is the listed applicant for BMLS16-1?

The FDA 510(k) record lists Biomedical Life Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BMLS16-1?

The FDA product code for BMLS16-1 is NUH.

Related Devices (Code: NUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics Limited K251958VEINOPLUS BackDynapulse Medical

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.