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)

PTR MK II VENTILATOR

K-Number: K860692 · 1986-05-21

ApplicantBear Medical Systems, Inc.
Decision Date1986-05-21
Product CodeBYT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PTR MK II VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Bear Medical Systems, Inc.. It received FDA 510(k) clearance on 1986-05-21 under 510(k) number K860692. The device is classified under product code BYT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PTR MK II VENTILATOR?

PTR MK II VENTILATOR is a medical device that received FDA 510(k) clearance on 1986-05-21. The listed applicant is Bear Medical Systems, Inc.. The 510(k) number is K860692.

When did PTR MK II VENTILATOR receive FDA 510(k) clearance?

PTR MK II VENTILATOR received FDA 510(k) clearance on 1986-05-21, under 510(k) number K860692.

Who is the listed applicant for PTR MK II VENTILATOR?

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

What is the FDA product code for PTR MK II VENTILATOR?

The FDA product code for PTR MK II VENTILATOR is BYT.

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

Other records listing Bear Medical Systems, 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.

K992788BEAR CUB 750 PSVK983981BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBEK912619BEAR 7 VENTILATORK900637BEAR CEM CONTROLLERK896315BEAR VH820 DISPOSABLE CHAMBER ASSEMBLYK893034VHS 820 HUMIDIFIER, MODIFICATION

View all 28 devices →

Related Devices (Code: BYT)

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.

K082657RTX RESPIRATORMedivent LimitedK072290PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUSDima Italia SrlK924341HAYEK OSCILLATOR(TM)Respironics, Inc.K910947NEV-10 NEGATIVE PRESSURE VENTILATORLifecare Services, Inc.K905530PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEMPuritan Bennett Corp.K902764EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARMJ. H. Emerson Co.

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.

↑