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FDA 510(k)

EMS

K-Number: K931401 · 1994-03-23

ApplicantSaratoga Intl., Inc.
Decision Date1994-03-23
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

EMS is the device name listed in this FDA 510(k) record. The listed applicant is Saratoga Intl., Inc.. It received FDA 510(k) clearance on 1994-03-23 under 510(k) number K931401. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMS?

EMS is a medical device that received FDA 510(k) clearance on 1994-03-23. The listed applicant is Saratoga Intl., Inc.. The 510(k) number is K931401.

When did EMS receive FDA 510(k) clearance?

EMS received FDA 510(k) clearance on 1994-03-23, under 510(k) number K931401.

Who is the listed applicant for EMS?

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

What is the FDA product code for EMS?

The FDA product code for EMS is IPF.

Related PubMed Literature

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.

PMID: 42711639Networked Radiology Imaging and Treatment Planning Systems and FDA Cybersecurity Regulation: A Difference-in-Differences Analysis of 510(k) Clearance Delays.Journal of imaging informatics in medicine ()PMID: 41694722Lessons from global materiovigilance systems: What India can learn?Perspectives in clinical research ()PMID: 39081796Recent Advances in the Design and Application of Shoulder Arthroplasty Implant Systems and Their Impact on Clinical Outcomes: A Comprehensive Review.Orthopedic research and reviews ()PMID: 37496031Adapting modeling and simulation credibility standards to computational systems biology.Journal of translational medicine ()

Other records listing Saratoga Intl., Inc. as applicant

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.

K896787TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION

Related Devices (Code: IPF)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

Official Source

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