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FDA 510(k)

PSI-TEC ASPIRATOR

K-Number: K980392 · 1998-03-05

ApplicantByron Medical
Decision Date1998-03-05
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PSI-TEC ASPIRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Byron Medical. It received FDA 510(k) clearance on 1998-03-05 under 510(k) number K980392. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PSI-TEC ASPIRATOR?

PSI-TEC ASPIRATOR is a medical device that received FDA 510(k) clearance on 1998-03-05. The listed applicant is Byron Medical. The 510(k) number is K980392.

When did PSI-TEC ASPIRATOR receive FDA 510(k) clearance?

PSI-TEC ASPIRATOR received FDA 510(k) clearance on 1998-03-05, under 510(k) number K980392.

Who is the listed applicant for PSI-TEC ASPIRATOR?

The FDA 510(k) record lists Byron Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PSI-TEC ASPIRATOR?

The FDA product code for PSI-TEC ASPIRATOR is BTA.

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Other records listing Byron Medical 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.

K040149PSI-TEC PERISTALTIC INFILTRATION PUMPK001803ACCELERATOR RECIPROCATING CANNULAK981215PSI-TEC LIPOSUCTION ASPIRATORK981172LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLESK980738PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATIONK974295BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING

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Related Devices (Code: BTA)

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.

K253629Momcozy Nasal Aspirator (BN007)Shenzhen Root Innovation Technology Co., Ltd.K260134Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)Shenzhen Root Innovation Technology Co., Ltd.K260892Suction Pump (SU-90)Shenzhen HugeMed Medical Technical Development Co., Ltd.K260473Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)Shenzhen Kingboom Technology Co., Ltd.K253107Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)Shenzhen Dongjiang Technology Co., Ltd.K260147Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)Shenzhen Kingboom Technology Co., Ltd.

Official Source

View on FDA Database →

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

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