Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MODEL 8800 ASPIRATOR

K-Number: K963775 · 1997-03-26

ApplicantMedical Specifics, Inc.
Decision Date1997-03-26
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL 8800 ASPIRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Medical Specifics, Inc.. It received FDA 510(k) clearance on 1997-03-26 under 510(k) number K963775. 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 MODEL 8800 ASPIRATOR?

MODEL 8800 ASPIRATOR is a medical device that received FDA 510(k) clearance on 1997-03-26. The listed applicant is Medical Specifics, Inc.. The 510(k) number is K963775.

When did MODEL 8800 ASPIRATOR receive FDA 510(k) clearance?

MODEL 8800 ASPIRATOR received FDA 510(k) clearance on 1997-03-26, under 510(k) number K963775.

Who is the listed applicant for MODEL 8800 ASPIRATOR?

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

What is the FDA product code for MODEL 8800 ASPIRATOR?

The FDA product code for MODEL 8800 ASPIRATOR is BTA.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

↑