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)

SKYVAL

K-Number: K973610 · 1997-12-19

ApplicantPyramid Air Systems
Decision Date1997-12-19
Product CodeFYD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SKYVAL is the device name listed in this FDA 510(k) record. The listed applicant is Pyramid Air Systems. It received FDA 510(k) clearance on 1997-12-19 under 510(k) number K973610. The device is classified under product code FYD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKYVAL?

SKYVAL is a medical device that received FDA 510(k) clearance on 1997-12-19. The listed applicant is Pyramid Air Systems. The 510(k) number is K973610.

When did SKYVAL receive FDA 510(k) clearance?

SKYVAL received FDA 510(k) clearance on 1997-12-19, under 510(k) number K973610.

Who is the listed applicant for SKYVAL?

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

What is the FDA product code for SKYVAL?

The FDA product code for SKYVAL is FYD.

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: FYD)

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.

K240127PlumeSafe X5 Smoke Management SystemConmed CorporationK2337898Q10 Surclear Smoke Plume Evacuation SystemSurnic CorporationK213068Medline Smoke Evacuation ShroudMedline Industries, Inc.K202944NEBULAE SRS Laparoscopic Surgical Smoke Removal SystemNorthgate Technologies, Inc.K200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF SensorMegadyne Medical Products, Inc.K192035EvaQMax Smoke Evacuation SystemBio Protech, Inc.

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.

↑