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FDA 510(k)

SPIRIT S1/S2

K-Number: K962071 · 1996-08-06

ApplicantPelton & Crane Co.
Decision Date1996-08-06
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SPIRIT S1/S2 is the device name listed in this FDA 510(k) record. The listed applicant is Pelton & Crane Co.. It received FDA 510(k) clearance on 1996-08-06 under 510(k) number K962071. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIRIT S1/S2?

SPIRIT S1/S2 is a medical device that received FDA 510(k) clearance on 1996-08-06. The listed applicant is Pelton & Crane Co.. The 510(k) number is K962071.

When did SPIRIT S1/S2 receive FDA 510(k) clearance?

SPIRIT S1/S2 received FDA 510(k) clearance on 1996-08-06, under 510(k) number K962071.

Who is the listed applicant for SPIRIT S1/S2?

The FDA 510(k) record lists Pelton & Crane Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPIRIT S1/S2?

The FDA product code for SPIRIT S1/S2 is EIA.

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Other records listing Pelton & Crane Co. 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.

K972249ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CDK972168SIDEXIS DIGITAL RADIOGRAPHY SYSTEMK945117DELTAK960819HELIODENT DSK950299CEREC 2K946187SPIRIT II AND SPIRIT TREATMENT CENTER

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Related Devices (Code: EIA)

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.

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, LLC

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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